NA 03.505.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10887587013312), received between Oct 17, 2018 and Feb 18, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT REMOVAL SURGERY. WHEN IT WAS DELIVERED THE DAY BEFORE SURGERY, IT WAS DISCOVERED THAT THE TURNING HANDLE COULD NOT BE ATTACHED TO THE HANDLE. IT WAS CONFIRMED THAT ALTHOUGH THERE WERE TIMES WHEN IT WAS NOT POSSIBLE TO ATTACH IT, IT WAS NOT COMPLETELY IMPOSSIBLE TO ATTACH IT. AS A RESULT, ADDITIONAL ARRANGEMENTS WERE QUICKLY MADE. THERE WAS NO IMPACT ON THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377771 ↗
• MalfunctionOct 15, 2024Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. THE MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS (MIPO) SYSTEM DID NOT WORK PROPERLY IN SURGERY AND WAS STICKING. THE ASSISTANT, WHEN REVIEWING THE PIECES AFTER SURGERY, FOUND THAT THE MOVING PARTS WERE UNLUBRICATED AND WITH DRY BLOOD RESIDUES. AS THE SYSTEM CONTAINS TWO OF EACH ITEM, OTHER DEVICES WERE AVAILABLE FOR USE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20450909 ↗
• MalfunctionMar 14, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT AN UNKNOWN SURGERY WAS PERFORMED ON (B)(6) 2024. THE METAL PART CAME OFF FROM THE HANDLE AND IT COULD NOT BE USED FOR SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE TURNING HANDLE F/90 SCRWDRVR FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18907362 ↗
• MalfunctionDec 8, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) , A DEFECT IN ENGAGEMENT BETWEEN DEVICES OCCURRED. WHEN THE DEVICES WERE CHECKED BEFORE WASHING AND STERILIZATION, THE DEVICES GOT DETACHED EASILY BECAUSE THE ENGAGEMENT BETWEEN THE HANDS AND TURNING HANDLES WAS LOOSE. THE DEVICES ARE UNABLE TO BE USED IN SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TURNING HANDLE F/90 SCRWDRVR. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15942505 ↗
• MalfunctionDec 8, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A DEFECT IN ENGAGEMENT BETWEEN DEVICES OCCURRED. WHEN THE DEVICES WERE CHECKED BEFORE WASHING AND STERILIZATION, THE DEVICES GOT DETACHED EASILY BECAUSE THE ENGAGEMENT BETWEEN THE HANDS AND TURNING HANDLES WAS LOOSE. THE DEVICES ARE UNABLE TO BE USED IN SURGERY. THIS REPORT IS FOR ONE (1) TURNING HANDLE F/90 SCRWDRVR. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15942490 ↗
• MalfunctionOct 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, THEY WERE UNABLE TO STERILIZE/ASSEMBLE THE GEAR NOT MATCHING OR WAS MALFUNCTIONING DURING STERILIZATION. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) TURNING HANDLE F/90 SCREWDRIVER. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12642801 ↗
• MalfunctionJun 21, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021, IN ORDER TO MAKE A BURR HOLE, THEY ASSEMBLED THE 90 DEGREE SCREWDRIVER COMPONENTS OUT OF A SCREWDRIVER KIT AND CONNECTED WITH A STRYKER¿S TPS (TOTAL PERFORMANCE SYSTEM). HOWEVER, THE STRYKER DID NOT START AND TRIED ASSEMBLING SPARE SCREWDRIVER COMPONENTS FROM THE SAME KIT, WHICH LEAD TO THE SAME RESULT. THEY TRIED ASSEMBLING THE DEVICE ONE MORE TIME AND IT WORKED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED. RCANEINSTR F/REMOVAL OF INSERTS (PRODUCT#: 05.505.003, LOT#: UNK, QUANTITY: 1). THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS REPORT IS FOR (1) TURNING HANDLE F/90 SCRWDRVR. THIS REPORT IS 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12031853 ↗
• MalfunctionJun 21, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021, IN ORDER TO MAKE A BURR HOLE, THEY ASSEMBLED THE 90 DEGREE SCREWDRIVER COMPONENTS OUT OF A SCREWDRIVER KIT AND CONNECTED WITH A STRYKER¿S TPS (TOTAL PERFORMANCE SYSTEM). HOWEVER, THE STRYKER DID NOT START AND TRIED ASSEMBLING SPARE SCREWDRIVER COMPONENTS FROM THE SAME KIT, WHICH LEAD TO THE SAME RESULT. THEY TRIED ASSEMBLING THE DEVICE ONE MORE TIME AND IT WORKED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED. RCANEINSTR F/REMOVAL OF INSERTS (PRODUCT#: 05.505.003, LOT#: UNK, QUANTITY: 1). THIS COMPLAINT INVOLVES (8) DEVICES. THIS REPORT IS FOR (1) TURNING HANDLE F/90 SCREWDRIVER. THIS REPORT IS 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12031811 ↗
• MalfunctionMar 3, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020, THAT THE TURNING HANDLE (03.505.005), THE SHAFT (03.505.003), THE HANDLE (03.505.004) MADE A NOISE WHEN IT WAS CONNECTED TO A HOSPITAL-OWNED POWER TOOL FOR MAKING A HOLE IN THE MANDIBULAR ANGLE DURING AN UNKNOWN SURGERY FOR FIX A PLATE TO THE MANDIBULAR ANGLE FRACTURE. ALSO, IT MADE A NOISE AGAIN WHEN ATTEMPTING TO INSERT THE SCREW BY HAND, AND TIP OF A DRIVER DID NOT ROTATE. THE SURGERY WAS COMPETED BY USING MMD-5 INSTEAD. THERE WAS ABOUT 1-HOUR SURGICAL DELAY. CONCOMITANT DEVICES REPORTED: UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS IS 1 OF 3 FOR REPORT (B)(4).

  Patient problems: No Code Available

  MAUDE report 9781940 ↗
• MalfunctionFeb 28, 2020Device-Device Incompatibility; Noise, Audible; Device-Device Incompatibility; Noise, Audible

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020, THAT THE TURNING HANDLE (03.505.005), THE SHAFT (03.505.003), THE HANDLE (03.505.004) MADE A NOISE WHEN IT WAS CONNECTED TO A HOSPITAL-OWNED POWER TOOL FOR MAKING A HOLE IN THE MANDIBULAR ANGLE DURING AN UNKNOWN SURGERY FOR FIX A PLATE TO THE MANDIBULAR ANGLE FRACTURE. ALSO, IT MADE A NOISE AGAIN WHEN ATTEMPTING TO INSERT THE SCREW BY HAND, AND TIP OF A DRIVER DID NOT ROTATE. THE SURGERY WAS COMPETED BY USING MMD-5 INSTEAD. THERE WAS ABOUT 1 HOUR SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES THREE (3) DEVICE. THIS IS 1 OF 3 FOR REPORT (B)(4).

  Patient problems: No Code Available

  MAUDE report 9768828 ↗
• MalfunctionDec 26, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A TURNING HANDLE FOR A SCREWDRIVER DID NOT CLIP ANYMORE DURING AN ORTHOGNATHIC SURGERY. THERE WAS NO SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) TURNING HANDLE F/90° SCRWDRVR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8197545 ↗
• MalfunctionOct 17, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE SCREWHOLDER FOR 90 DEGREES SCREWDRIVER WAS NOTED TO HAVE DIFFICULTY SLIDING WHEN USED WITH THE HANDLE FOR 90 DEGREES SCREWDRIVER. IT WAS ALSO NOTED THAT THE TURNING HANDLE FOR 90 DEGREES SCREWDRIVER WAS ALSO HAVING A DIFFICULTY IN SLIDING SINCE THE PLATING IS PEELING OFF. THERE WAS NO PATIENT INVOLVEMENT REPORTED. IT IS UNKNOWN HOW THE MALFUNCTION WAS DISCOVERED. THIS REPORT IS FOR A TURNING HANDLE FOR 90° SCREWDRIVER. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7974465 ↗