NA 323.050Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10886982190697), received between Jul 11, 2019 and Jan 21, 2026 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (18 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 21, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION, THE REPORTER IDENTIFIED DAMAGE TO TWO PROXIMAL HUMERUS GUIDE BLOCKS. THE CONNECTING SCREW INTERFACE SEEMS TO NOT WANT TO ALLOW SCREW CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24129726 ↗
• MalfunctionJan 21, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION, THE REPORTER IDENTIFIED DAMAGE TO TWO PROXIMAL HUMERUS GUIDE BLOCKS. THE CONNECTING SCREW INTERFACE SEEMS TO NOT WANT TO ALLOW SCREW CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24129710 ↗
• MalfunctionNov 17, 2025Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT UPON ROUTINE INSPECTION ON AN UNKNOWN DATE, IT WAS NOTICED THAT THE SET SCREW WAS DISLODGED ON THE PH GUIDE BLOCK. A REPLACEMENT WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23572559 ↗
• MalfunctionOct 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE THAT GUIDE BLOCK DOESN'T SCREW ON AND ATTACH ANYMORE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23370897 ↗
• MalfunctionOct 22, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSERTION GUIDE WON¿T CONNECT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360454 ↗
• MalfunctionSep 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 , A DRILL GUIDE BLOCK IS NOT ATTACHING PROPERLY ON THE PLATES AND SCREW IS STRIPPED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) INSERTION GUIDE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20206527 ↗
• MalfunctionJun 13, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2024 DURING A PROXIMAL FEMUR FRACTURE CASE, DOCTOR HAS GUIDANCE BLOCK PLATE AND HE INSERTED A 1.6 K-WIRE TO SLOT OF THE TOP OF THE GUIDE BLOCK AND INSERTION GUIDE. THE K-WIRE GOT STUCK IN A GUIDE BLOCK AND ITEM REMOVED SUCCESSFULLY BY MOVING THE GUIDE WIRE. THE PATIENT WAS NOT AFFECTED, AND SURGERY DONE SUCCESSFULLY. THIS IS NOTICED HALF OF CASE COMPLETED. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) INSERTION GUIDE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19532066 ↗
• MalfunctionAug 3, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING AN OPEN REDUCTION/INTERNAL FIXATION SURGERY FOR THE PROXIMAL HUMERUS ON (B)(6) 2023, WHEN TRYING TO REMOVE A KIRSCHNER NAIL THAT WAS PLACED IN THE UPPER HOLE, IT BROKE, AND A PIECE OF THE NAIL GOT TRAPPED IN THE GUIDE FOR PHILOS PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY, AND THE ISSUE WAS RESOLVED BY FIXING THROUGH ANOTHER HOLE. THIS REPORT INVOLVES ONE INSERTION GUIDE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17452588 ↗
• MalfunctionApr 19, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 DURING ROUTING MEDICAL DEVICE REPROCESSING, STAFF IDENTIFIED THAT THE LITTLE SCREW WHICH IS PART OF THE DEVICE IN QUESTION WOULD NOT THREAD FULLY INTO THE BODY OF THE GUIDE BLOCK. THIS IS NECESSARY FOR THE GUIDE BLOCK TO CORRECTLY ATTACH TO THE PROXIMAL HUMERUS PLATE DURING NORMAL USE. IT WAS DETERMINED THAT THE DEVICE WAS NO LONGER FUNCTIONAL AND WAS SUBSEQUENTLY DISCARDED. THERE WAS NO REPORTED PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN INSERTION GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770972 ↗
• MalfunctionMar 8, 2023Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, UPON ROUTINE INSPECTION WHILE RESTOCKING THE INSTRUMENT TRAY A BROKEN SCREW WAS NOTICED WHICH WAS STUCK IN THE GUIDE BLOCK. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) INSERTION GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16501481 ↗
• MalfunctionJun 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING ON OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE PROXIMAL HUMERUS, THE K-WIRE BECAME STUCK IN PROXIMAL HOLE OF PHILOS PLATE INSERTION GUIDE/GUIDE BLOCK. THERE WAS NO REPORTED SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) INSERTION GUIDE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14630854 ↗
• MalfunctionApr 6, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT SHAFT IS OFF AXIS. THIS COMPLAINT INVOLVES (1) DEVICE INSERTION GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14021904 ↗
• MalfunctionApr 4, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSERTION GUIDE BROKE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE INSERTION GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13999739 ↗
• MalfunctionMar 30, 2022Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, DURING THE PROCEDURE, THE K-WIRE BROKE OFF IN THE GUIDE BLOCK AND STUCK IN IT. IT COULD NOT BE REMOVED. THERE WAS NO SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR ONE (1) INSERTION GUIDE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13956112 ↗
• MalfunctionFeb 18, 2022Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THE SCREW IN THE INSERTION GUIDE IS BROKEN. IT WAS NOTED NO FRAGMENTS WERE GENERATED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CONSEQUENCES FOR THE PATIENT. THIS REPORT IS FOR AN INSERTION GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559686 ↗
• InjuryNov 23, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT HAD AND ORIF OF A PROXIMAL HUMERUS FRACTURE AND THE SURGEON LEFT THE INSERTION GUIDE (323.050) ATTACHED TO THE PLATE AND CLOSED THE PATIENT. THE INSERTION GUIDE WAS STILL ATTACHED UNTIL FOLLOW UP ON (B)(6) 2021. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) INSERTION GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12863061 ↗
• MalfunctionSep 24, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE GUIDE WAS OFFSET. THIS REPORT IS FOR (1) INSERTION GUIDE THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12529020 ↗
• MalfunctionSep 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE INSERTION GUIDE COLD WELDED TO THE HOLE IN THE 1.6MM WIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - CABLE/WIRE: (PART# UNKNOWN; LOT# UNKNOWN; QUALITY:1) THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) INSERTION GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12415457 ↗
• MalfunctionSep 1, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE INSERTION GUIDE COLD WELDED TO THE HOLE IN THE 1.6MM WIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) INSERTION GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12408409 ↗
• MalfunctionJun 4, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A HUMERAL PLATE GUIDE WAS NOT WORKING, THE SCREW DOES NOT SEAT IN THE PLATE PROPERLY. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) INSERTION GUIDE. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939280 ↗
• MalfunctionJun 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THAT A K-WIRE BECAME STUCK IN THE MOST PROXIMAL HOLE OF THE INSERTION GUIDE AND WAS UNABLE TO BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11920434 ↗
• MalfunctionMay 27, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE BROKEN AIMING DEVICE WAS IDENTIFIED. THE PIN IN THE PIN HOLE WAS BROKEN AND COULD NOT BE REMOVED. THIS REPORT INVOLVES ONE (1) INSERTION GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11894266 ↗
• MalfunctionApr 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING INSPECTION UPON DELIVERY ON (B)(6) 2021, THE GUIDE WIRE 1.6 MM WOULD NOT FIT INTO THE GUIDE HOLE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR AN INSERTION GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11749190 ↗
• MalfunctionJan 29, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS, IT WAS DISCOVERED THAT SOME INSTRUMENTS WERE DAMAGED. THE STAR DRIVE SCREWDRIVER SHAFT IS BENT AND WOBBLES IN THE SCREWDRIVER HANDLE, WIRE GUIDE SLEEVE WON'T FULLY INSERT INTO THE BLADE GUIDE, BLADE/SCREW GUIDE SLEEVE WILL NOT LET THE BLADE INSERTER ENGAGE THE RIFLING PROPERLY, TUBE PART OF DEPTH GAUGE FOR SCREWS IS BENT AND WILL NOT LET THE SCREW DOWN PIECE ENGAGE THE THREADS, THE INSERTION GUIDE WAS BENT AND THE SLEEVES WERE UNABLE TO BE INSERTED FULL. HOWEVER, IT WAS SET ASIDE AND INADVERTENTLY PLACED IN THE SHARPS CONTAINER BY THE STAFF AND WAS UNABLE TO BE RETRIEVED. THERE WAS NO PATIENT INVOLVEMENT WITH ANY OF THESE ITEMS. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. CONCOMITANT PRODUCTS: DEPTH GAUGE FOR SCREWS Ø 2.7 TO 4.0 MM, MEASURING RANGE UP TO 60 MM, 3.2MM WIRE GUIDE SLEEVE, BLADE/SCREW GUIDE SLEEVE, DEPTH GAUGE FOR SCREWS Ø 2.7 TO 4.0 MM, INSERTION GUIDE. THIS REPORT IS FOR ONE (1) INSERTION GUIDE. THIS REPORT IS 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11252022 ↗
• MalfunctionSep 6, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2019 A GUIDE WIRE HAD BECOME STUCK IN ONE OF THE HOLES OF A PHILOS INSERTION GUIDE AND HAD BROKEN OFF IN THE INSTRUMENT DURING THE SURGERY. WHILE DISASSEMBLY FOR CLEANING, A MEDICAL PROFESSIONAL SCRATCHED HIMSELF WITH THE BROKEN GUIDE WIRE. NO SURGICAL DELAY WAS REPORTED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8970630 ↗