NA 357.071Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982195760), received between Jul 28, 2017 and Feb 1, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE THREAD OF THE HAMMER GUIDE WAS DEFECTIVE AND COULD NOT BE CONNECTED TO THE NAIL. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) HAMMER GUIDE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13415369 ↗
• MalfunctionSep 11, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020, THERE WERE PROBLEMS REMOVING THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA). THE EXTRACTION SCREW AND HAMMER GUIDE BECAME TWISTED. FRAGMENTS WERE GENERATED BUT WERE EASILY REMOVED. DIFFERENT INSTRUMENTS WERE USED TO COMPLETE THE CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF THREE HUNDRED AND SIXTY (360) MINUTES. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: PFNA NAIL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), PFNA BLADE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), HAMMER GUIDE (PART: 357.071, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR (1) HAMMER GUIDE. THIS IS REPORT 1 OF 1 (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10521440 ↗
• MalfunctionApr 8, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2020, DURING THE INSERTION OF THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA), THE HAMMER GUIDE WOULD NOT THREAD TIGHTLY TOGETHER WITH THE AIMING ARM FOR THE PFNA BLADE. ALTHOUGH, THE SETUP WAS NOT TIGHT THE SURGEON MALLETED THE NAIL IN. THERE WAS A SURGICAL DELAY OF FIVE (5) TO SEVEN (7) MINUTES. NO FRAGMENTS WERE GENERATED, AND NO NEW FRACTURES WERE CREATED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE AIMING ARM FOR THE PFNA BLADE WAS REPORTED AS IN GOOD CONDITION POST OPERATIVELY. THE THREADED PART OF THE HAMMER GUIDE WAS REPORTED AS WORN OUT POST OPERATIVELY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: NAILS: PFNA-II (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), HAMMER/MALLET (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), AIM-ARM 130° F/PFNA BLADE (PART NUMBER 03.010.407, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) HAMMER GUIDE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9938005 ↗
• MalfunctionOct 31, 2017Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE THREADED PART AT TIP OF THE HAMMER GUIDE BROKE OF INTRAOPERATIVELY. THERE WAS A SURGERY PROLONGATION OF 30 MINUTES. NO INFORMATION ABOUT PATIENT OUTCOME. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. FRAGMENTS WERE GENERATED BUT WERE REMOVED FROM THE PATIENT. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6991547 ↗
• MalfunctionAug 17, 2017Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE THREAD AT THE DISTAL TIP OF THE HAMMER GUIDE IS DEFORMED AND WEAK. ISSUE WAS DISCOVERED DURING THE CLEANING PROCESS, NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HAMMER GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6800652 ↗
• MalfunctionJul 28, 2017Bent; Device Operates Differently Than Expected; Bent; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PARTS WERE DETECTED AS DAMAGED DURING INTERNAL INSPECTION OF LOANER KITS. REPORTEDLY THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A HAMMER GUIDE WHICH REPORTEDLY WAS DAMAGED. WHEN THE DEVICE WAS RECEIVED, IT WAS NOTED THAT THE THREADS WERE BEND/MALFORMED. THIS REPORT IS FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6751090 ↗
• MalfunctionJul 28, 2017Dull, Blunt; Device Operates Differently Than Expected; Dull, Blunt; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PARTS WERE DETECTED AS DAMAGED DURING INTERNAL INSPECTION OF LOANER KITS. REPORTEDLY THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A HAMMER GUIDE WHICH REPORTEDLY WAS DAMAGED. WHEN THE DEVICE WAS RECEIVED, IT WAS NOTED THAT THE THREADS WERE STRIPPED. THIS REPORT IS FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6751088 ↗