LCP 03.120.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982074034), received between Apr 8, 2019 and Jan 10, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING A PROCEDURE THE SURGEON WAS USING A 4.5 PROXIMAL TIBIA AIMING ARMS. ONE OF THE GUIDE SLEEVES WOULD NOT PROPERLY SNAP INTO THE AIMING ARM. THE AIMING ARM ALSO DID NOT PERFECTLY ALIGN WITH THE PLATE. THE SURGEON RECOMMENDED REPLACING THE INSERTION HANDLE AND AIMING ARM BECAUSE HE FELT THEY WERE NOT FUNCTIONING PROPERLY. THE SURGEON WAS ABLE TO COMPLETE THE SURGERY WITH NO DELAYS. THIS REPORT IS FOR ONE (1) PERIART INSRT HNDL 4.5 LCP PRX TIB PL-LT THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18483614 ↗
• MalfunctionJan 2, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT PERIARTICULAR AIMING ARM CAN NOT BE FIXED ON THE INSERTION HANDLE. IT WAS NOT REPORTED THAT THERE WAS ANY SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN PERIARTICULAR AIMING ARM (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9539808 ↗
• MalfunctionDec 19, 2019Device-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, AFTER SURGERY, THE AIMING ARM DOES NOT SCREW WITHIN THE PERIARTICULAR INSERTION HANDLE (PROBABLY STRIPPED). NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN AIMING ARM (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) PERIARTICULAR INSERTION HANDLE FOR 4.5MM LCP PROX TIBIA PL-LT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9495126 ↗
• MalfunctionApr 8, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING HAND SURGERY, A SCREWDRIVER HANDLE WAS NOT CONNECTING TO THE SCREWDRIVER SHAFT AND A DEPTH GAUGE WITH A BENT TIP. THERE WERE FEW DIFFERENT SHAFTS TRIED BUT WAS UNSUCCESSFUL IN GETTING A CONNECTION. THERE WAS NO SURGICAL DELAY. PROCEDURE OUTCOME WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS NOT AFFECTED. CONCOMITANT DEVICE: UNKNOWN SCREWDRIVER SHAFT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICES. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8493770 ↗