NA 03.010.085Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982067555), received between Nov 15, 2017 and Jun 24, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2019Incorrect Measurement; Incorrect Measurement

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE FOR A PATIENT WITH A FEMORAL SHAFT FRACTURE, THE GUIDE WIRE AND THE DIRECT MEASURING DEVICE FOR GUIDE WIRES DOES NOT PRODUCE AN EFFECTIVE SCREW LENGTH BASED ON THE SURGICAL TECHNIQUE OF THE EXPERT A2FN. IT WAS ALSO REPORTED THAT THE SURGEON FOLLOWED THE PROCEDURE AND FOUND THAT THE MEASURED LENGTH OF THE HIP SCREW USING THE 400 MM 3.2MM GUIDE WIRE AND THE DIRECT MEASURING DEVICE FOR GUIDE WIRES WERE NOT THE EFFECTIVE SCREW LENGTH, BUT 5MM SHORTER THAN MEASURED. THE SURGEON USED THE CORRECT INSTRUMENTS AND MEASURED AN 85MM HIP SCREW, THEN INSERTED THIS IN THE PATIENT AND FOUND OUT THAT THE HIP SCREW WAS 5MM LONGER. SO, THE SURGEON HAS TO OPEN AN 80MM HIP SCREW WHICH WAS A SHORTER SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A SURGICAL DELAY OF TEN (TEN) MINUTES. PATIENT AND PROCEDURE OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE/S REPORTED: EXPERT A2FN NAIL ( PART# 04.009.453S, PART# 8149447, QUANTITY), HIP SCREW 75MM ( PART# 04.003.025S, LOT# 7519970, QUANTITY 1), HIP SCREW 85MM ( PART# 04.003.027S, LOT# 8232286, QUANTITY 1). THIS COMPLAINT INVO

  Patient problems: No Code Available

  MAUDE report 8728515 ↗
• MalfunctionNov 15, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT MULTIPLE INSTRUMENTS MALFUNCTIONED DURING A LATERAL ENTRY FEMORAL NAILING TO REPAIR A MIDSHAFT FEMUR FRACTURE DUE TO A MOTOR VEHICLE ACCIDENT ON (B)(6) 2017. AFTER THE SURGEON INSERTED THE NAIL, HE INSERTED THE THREE-PART TROCAR ASSEMBLY, HE THEN CHECKED TO MAKE SURE IT WAS BEING TARGETED CORRECTLY. WHEN HE WENT TO INSERT THE GUIDE WIRE, IT KEPT HITTING THE NAIL AND WAS MISALIGNED. THE MISALIGNMENT ISSUE ONLY HAPPENED WITH ONE GUIDE WIRE AND FIRST SET OF THE THREE-PART TROCAR ASSEMBLY. LATER IN THE PROCEDURE, HE ATTEMPTED TO TAKE THE NAIL OUT, BUT THE HAMMER KEPT GETTING JAMMED AND WOULDN¿T ROCK BACK AND FORTH ON THE HAMMER GUIDE, HE STRUGGLED TO GET THE NAIL OUT. THEN, AS THE DEPTH GAUGE WAS BEING USED TO MEASURE THE LENGTH OF THE RECON SCREWS; THE SURGEON TRIED THREE TIMES AND THE MEASUREMENT WAS INACCURATE, IT WAS 10 MM LONGER THAN NEEDED. THERE WAS A REPORTED SURGICAL DELAY OF 10 MINUTES TO TAKE THE NAIL OUT AND REPOSITION IT. NO ADDITIONAL X-RAYS OR OTHER MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS COMPLAINT INVOLVES NINE (5) DEVICES. CONCOMITANT DEVICES REPORTED: HAMMER GUIDE (QUANTITY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7035659 ↗