NA 03.124.006Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982075000), received between Mar 28, 2019 and Jan 13, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, THE TIBIAL PLATEAU PLATE HOLE AND INTERLOCKING NUT STRIPPED. ANOTHER SET WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO GENERATION OF FRAGMENTS. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24056978 ↗
• MalfunctionNov 2, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) RIGHT LATERAL TIBIA PLATEAU FRACTURE. DURING THE PROCEDURE, THE CANNULATED INTERLOCKING BOLT WOULD NOT THREAD INTO THE PERCUTANEOUS AIMING ARM HOLE OF A LATERAL PROXIMAL TIBIA PLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FIVE (5) MINUTE SURGICAL DELAY. THE PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICE REPORTED: UNKNOWN NUT (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1); UNKNOWN INSERTION HANDLE (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) 2.8MM INTERLOCKING BOLT FOR PERCUTANEOUS INSERTION HANDLE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10772370 ↗
• MalfunctionMay 4, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, THE NUT FOR INTERLOCKING BOLTS FOR PERCUTANEOUS INSERTION HANDLE WAS DIFFICULT TO THREAD ONTO THE INTERLOCKING BOLT FOR PERCUTANEOUS INSERTION HANDLE. THE TECHNICIAN WAS UNABLE TO USE THE 2 DEVICES TO ATTACH THE UNKNOWN AIMING ARM TO THE UNKNOWN PLATE. THE SURGEON HAD TO ASSIST THE TECHNICIAN AT THE BACK OF THE TABLE TO COMPLETE THE ASSEMBLY. THE SURGEON HAD TO STOP WHAT HE WAS DOING TO ASSIST THE TECHNICIAN IN THE ASSEMBLY OF THE PARTS TO COMPLETE THE SURGERY SUCCESSFULLY. IT WAS TOO DIFFICULT TO THREAD AND HAVE THESE 2 DEVICES LOOKED AT. THERE WAS A SURGICAL DELAY OF 2 MINUTES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN AIMING ARM (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES 2 DEVICES. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10021957 ↗
• MalfunctionDec 6, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019 DURING AN UNKNOWN SURGERY TWO (2) INTERLOCKING BOLTS FOR A PERCUTANEOUS INSERTION HANDLE WOULD NO LONGER SCREW INTO THE PLATE. IT IS UNKNOWN IF THERE WAS A PROCEDURE OR PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 2.8MM INTERLOCKING BOLT FOR PERCUTANEOUS INSERTION HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9429598 ↗
• MalfunctionMar 28, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE THREAD OF FOUR VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) PROXIMAL TIBIA PLATES SCREW HOLE WAS BROKEN BY TWO (2) INTERLOCKING BOLT. IT WAS NOTED IT HAD BEEN CONNECTED VERY CAREFULLY. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) INTERLOCKING BOLT. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8460411 ↗