NA 03.614.019Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10705034714905), received between May 12, 2017 and Jun 8, 2023 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (10 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN KUWAIT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, AFTER OPENING THE ITEM, THE SYNAPSE HOLD SL WAS NOT ALLOWING THE QUICK COUPLING STARDRIVE SYNAPSE SCREWDRIVER SHAFT TO INSERT IN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17086015 ↗
• MalfunctionFeb 3, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DO TO OVERUSE AND WEAR AND TEAR, THE TIP OF THE T15 SYNAPSE DRIVER FOR THE LOCKING SET SCREWS IS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY IN SURGERY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) STARDRV SCRDRVR SHAFT T15/SELF-RETAIN QC THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16293475 ↗
• MalfunctionJun 8, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, THE SCREWDRIVER TIP IS ROUNDED AND STRIPPING SET OF SCREWS. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11959085 ↗
• MalfunctionMar 26, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A FINAL TIGHTENING SCREWDRIVER SHAFT SEEMED TO BE SLIPPING AND THEREFORE STRIPPING SET SCREWS WHEN USED WITH THE TORQUE HANDLE. THE ADDITIONAL TORQUE SHAFT IN THE SETS WERE UTILIZED. NO FRAGMENTS GENERATED, PROCEDURE WAS SUCCESSFULLY COMPLETE. CONCOMITANT DEVICES REPORTED: UNKNOWN SETSCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN), UNKNOWN TORQUE HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575159 ↗
• MalfunctionJun 10, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER TIP WAS DISCOVERED AS STRIPPED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10138283 ↗
• MalfunctionDec 23, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2019, THE STARDRIVE SCREWDRIVER SHAFT BECAME BURRED. SURGEON USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT AND NO DELAY IN THE SURGERY REPORTED. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9512365 ↗
• MalfunctionNov 6, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES, REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, ON AN UNKNOWN DATE, DURING AN UNKNOWN OPERATION, TIP OF THE SCREWDRIVER IN QUESTION IS STRIPPED AND WON¿T TIGHTEN SET SCREWS. PATIENT OUTCOME AND SURGERY OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SCRDRIVER SHAFT F/LOCKSCR T15. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9284336 ↗
• MalfunctionAug 21, 2019Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED A TORQUE SHAFT IS STRIPPED. IT IS UNKNOWN WHEN THE MALFUNCTION OCCURRED. THERE IS NO REPORT OF PATIENT CONSEQUENCE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8914818 ↗
• MalfunctionJan 23, 2019Material Twisted/Bent; Naturally Worn; Device Difficult to Maintain; Material Twisted/Bent; Naturally Worn; Device Difficult to Maintain

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2018, DURING THE PROCEDURE, TWO (2) STARDRIVE SCREWDRIVER SHAFT WAS UNABLE TO RETAIN THE SCREW WHEN THE SURGEON INSERTED THE SETSCREW. THERE WAS A SURGERY DELAY OF LESS THAN 30 MINUTES. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8272193 ↗
• MalfunctionJan 23, 2019Material Twisted/Bent; Naturally Worn; Device Difficult to Maintain; Material Twisted/Bent; Naturally Worn; Device Difficult to Maintain

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2018, DURING THE PROCEDURE, TWO (2) STARDRIVE SCREWDRIVER SHAFT WAS UNABLE TO RETAIN THE SCREW WHEN THE SURGEON INSERTED THE SETSCREW. THERE WAS A SURGERY DELAY OF LESS THAN 30 MINUTES. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 8272190 ↗
• MalfunctionDec 5, 2018Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, ALL FOUR (4) SCREWDRIVER SHAFT TIPS WERE FOUND TO BE ROUNDED AND SURGEON HAD TROUBLE ON THE FINAL TIGHTENING THE UNKNOWN SET SCREWS. AS A RESULT, EIGHT (8) OF THE UNKNOWN SET SCREWS WERE STRIPPED. SURGEON MANAGED TO FINAL TIGHTEN ALL THE UNKNOWN SET SCREWS BUT EIGHT (8) UNKNOWN SET SCREWS WERE WASTED IN THE PROCESS DUE TO THE BLUNT SCREWDRIVERS SHAFT. THERE WAS A TEN (10) MINUTES DELAY TO THE PROCEDURE. THERE WAS NO ADVERSE EVENT TO THE PATIENT REPORTED. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8134202 ↗
• MalfunctionDec 5, 2018Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, ALL FOUR (4) SCREWDRIVER SHAFT TIPS WERE FOUND TO BE ROUNDED AND SURGEON HAD TROUBLE ON THE FINAL TIGHTENING THE UNKNOWN SET SCREWS. AS A RESULT, EIGHT (8) OF THE UNKNOWN SET SCREWS WERE STRIPPED. SURGEON MANAGED TO FINAL TIGHTEN ALL THE UNKNOWN SET SCREWS BUT EIGHT (8) UNKNOWN SET SCREWS WERE WASTED IN THE PROCESS DUE TO THE BLUNT SCREWDRIVERS SHAFT. THERE WAS A TEN (10) MINUTES DELAY TO THE PROCEDURE. THERE WAS NO ADVERSE EVENT TO THE PATIENT REPORTED. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 3 OF 5 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8134187 ↗
• MalfunctionDec 5, 2018Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, ALL FOUR (4) SCREWDRIVER SHAFT TIPS WERE FOUND TO BE ROUNDED AND SURGEON HAD TROUBLE ON THE FINAL TIGHTENING THE UNKNOWN SET SCREWS. AS A RESULT, EIGHT (8) OF THE UNKNOWN SET SCREWS WERE STRIPPED. SURGEON MANAGED TO FINAL TIGHTEN ALL THE UNKNOWN SET SCREWS BUT EIGHT (8) UNKNOWN SET SCREWS WERE WASTED IN THE PROCESS DUE TO THE BLUNT SCREWDRIVERS SHAFT. THERE WAS A TEN (10) MINUTES DELAY TO THE PROCEDURE. THERE WAS NO ADVERSE EVENT TO THE PATIENT REPORTED. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4) .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8134151 ↗
• MalfunctionDec 5, 2018Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, ALL FOUR (4) SCREWDRIVER SHAFT TIPS WERE FOUND TO BE ROUNDED AND SURGEON HAD TROUBLE ON THE FINAL TIGHTENING THE UNKNOWN SET SCREWS. AS A RESULT, EIGHT (8) OF THE UNKNOWN SET SCREWS WERE STRIPPED. SURGEON MANAGED TO FINAL TIGHTEN ALL THE UNKNOWN SET SCREWS BUT EIGHT (8) UNKNOWN SET SCREWS WERE WASTED IN THE PROCESS DUE TO THE BLUNT SCREWDRIVERS SHAFT. THERE WAS A TEN (10) MINUTES DELAY TO THE PROCEDURE. THERE WAS NO ADVERSE EVENT TO THE PATIENT REPORTED. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8134119 ↗
• MalfunctionOct 22, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, IT WAS NOTED FOUR INSTRUMENTS WERE BROKEN: TWO (2) THREADED HOLDING SLEEVE, A DRILL GUIDE WITH GRADUATION AND A STARDRIVE SCREWDRIVER SHAFT. THERE IS NO PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR A THREADED HOLDING SLEEVE. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7990882 ↗
• MalfunctionMay 11, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A POSTERIOR SPINAL FUSION PROCEDURE, THE SURGEON WAS PERFORMING THE FINAL TIGHTENING ON THE SYNAPSE SET SCREWS. THE DISTAL TIP OF THE STARDRIVE SCREWDRIVER WAS STRIPPED, AND DID NOT TIGHTEN THE SCREWS. ANOTHER STARDRIVE SCREWDRIVER WAS AVAILABLE IN THE SET, AND IT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY, NO REPORTED FRAGMENTS GENERATED, AND NO REPORTED PATIENT HARM. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7506153 ↗
• MalfunctionApr 11, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SPINAL FUSION PROCEDURE ON (B)(6) 2018, THE TIP OF A STARDRIVE SCREWDRIVER SHAFT WAS STRIPPED DURING FINAL TIGHTENING OF A SCREW. A SECOND SCREWDRIVER WAS READILY AVAILABLE (WAS INCLUDED IN THE SET) AND USED TO COMPLETE THE SURGERY. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7421184 ↗
• InjuryFeb 16, 2018Dull, Blunt; Dull, Blunt

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ABOUT A C4-T2 POSTERIOR INSTRUMENTED FUSION AT (B)(6) HOSPITAL (B)(6) 2018. DURING USE ON PATIENT, T15 STARDRIVE STRIPPED AND FAILED TO TORQUE OFF SET SCREW. HOLDING SLEEVE WITH THREAD, UNABLE TO LOAD SCREW ONTO DRIVER. 2.4MM DRILL BIT BLUNT AND UNUSABLE, USED SAME LIKE PRODUCT TO MANAGE PROBLEM DURING PROCEDURE. NO ADVERSE EVENT TO PATIENT, 5 MINUTES DELAY TO PROCEDURE THIS COMPLAINT INVOLVES ONE PART. (B)(4).

  Patient problems: No Code Available

  MAUDE report 7277291 ↗
• MalfunctionJan 24, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  (B)(4) REPORTED THAT DURING FINAL TIGHTENING OF THE SYNAPSE SET SCREW IN AN UNKNOWN PROCEDURE ON (B)(6) 2018. IT WAS NOTICED THE STARDRIVE SCREWDRIVER TIP SEEMED ROUNDED OFF. THE SURGEON EXCHANGED THE DEVICE FOR ANOTHER SHAFT AND COMPLETED THE FINAL TIGHTENING. THERE IS NO REPORT OF SURGICAL DELAY OR PATIENT HARM. PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: SYNAPSE SET SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7215290 ↗
• MalfunctionDec 4, 2017Dull, Blunt; Dull, Blunt

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DURING A C2-C7 LEVEL POSTERIOR CERVICAL FUSION PROCEDURE PERFORMED ON (B)(6) 2017; SURGEON WAS TORQUEING OFF SET SCREWS WITH STARDRIVE SCREWDRIVER SHAFT AND THE SHAFT STRIPPED AND SURGEON WAS UNABLE TO TORQUE. SECOND STARDRIVE SCREWDRIVER SHAFT WAS USED AND THE SAME THING HAPPENED. SURGEON USED THE T15 DRIVER IN THE H2H KIT AND TORQUED OFF. THE SURGERY WAS DELAYED BY TEN (10) MINUTES, THERE IS NO CONSEQUENCE FOR THE PATIENT. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7080814 ↗
• MalfunctionDec 4, 2017Dull, Blunt; Dull, Blunt

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DURING A C2-C7 LEVEL POSTERIOR CERVICAL FUSION PROCEDURE PERFORMED ON (B)(6) 2017; SURGEON WAS TORQUEING OFF SET SCREWS WITH STARDRIVE SCREWDRIVER SHAFT AND THE SHAFT STRIPPED AND SURGEON WAS UNABLE TO TORQUE. SECOND STARDRIVE SCREWDRIVER SHAFT WAS USED AND THE SAME THING HAPPENED. SURGEON USED THE T15 DRIVER IN THE H2H KIT AND TORQUED OFF. THE SURGERY WAS DELAYED BY TEN (10) MINUTES, THERE IS NO CONSEQUENCE FOR THE PATIENT. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7080801 ↗
• MalfunctionSep 14, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, DURING THE PROCEDURE, TWO DRIVERS WERE SLIPPING ON FINAL TIGHTENING, SUGGESTING THAT THEY ARE BECOMING WORN AT THE DISTAL TIP. REPORTEDLY, THE SURGEON USED THE SAME DRIVER TO PERFORM TIGHTENING AND DID SO SUCCESSFULLY. THERE WAS NO PATIENT IMPACT. THE SURGERY WAS NOT PROLONGED AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6866480 ↗
• MalfunctionSep 14, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, DURING THE PROCEDURE, TWO DRIVERS WERE SLIPPING ON FINAL TIGHTENING, SUGGESTING THAT THEY ARE BECOMING WORN AT THE DISTAL TIP. REPORTEDLY, THE SURGEON USED THE SAME DRIVER TO PERFORM TIGHTENING AND DID SO SUCCESSFULLY. THERE WAS NO PATIENT IMPACT. THE SURGERY WAS NOT PROLONGED AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6866465 ↗
• MalfunctionAug 22, 2017Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT TWO (2) T15 SELF-RETAINING STARDRIVE SCREWDRIVER SHAFTS HAVE WORN TIPS. THIS WAS DISCOVERED DURING ROUTINE INSPECTION. NO PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) T15 STARDRIVE SCREWDRIVER SHAFT. (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6811931 ↗
• MalfunctionAug 22, 2017Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT TWO (2) T15 SELF-RETAINING STARDRIVE SCREWDRIVER SHAFTS HAVE WORN TIPS. THIS WAS DISCOVERED DURING ROUTINE INSPECTION. NO PROCEDURE OR PATIENT INVOLVEMENT.THIS REPORT IS FOR ONE (1) T15 STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6811840 ↗