NA 391.905Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982198396), received between Jun 30, 2017 and Aug 27, 2026 — classified as 7 malfunctions.

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

• MalfunctionAug 27, 2026Break; Material Deformation

  It was reported on (b)(6) 2026 that bent instruments tip broken.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50474915 ↗
• MalfunctionDec 5, 2022Crack; Material Deformation; Crack; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON INSPECTION IN MDR ON (B)(6) 2022, ITEM 391.905 HAD DAMAGED BLADES AND NEEDS REPLACING. THE CUTTER HAD SUFFERED DAMAGE DURING USE, AND THE BLADES WERE DENTED/CRACKED. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CABLE CUTTER-STANDARD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15915100 ↗
• MalfunctionSep 2, 2022Break; Break

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 09-AUGUST-2022, THE CABLE CUTTER WAS FOUND TO HAVE BROKEN AND NO LONGER FUNCTIONS. THERE WAS NO REPORTED PATIENT INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A CABLE CUTTER-STANDARD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15352133 ↗
• MalfunctionOct 11, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE CUTTER (391.905) IS BROKEN AT THE DISTAL SCREW. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES. THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9181564 ↗
• MalfunctionMar 15, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  (B)(6) DOCUMENTED THE FOLLOWING: IT WAS REPORTED THAT TWO (2) CABLE CUTTERS BROKE DURING A PRIMARY STERNOTOMY PROCEDURE ON (B)(6) 2018. THE SURGEON WAS ATTEMPTING TO CUT A ZIPFIX WITH THE CABLE CUTTERS AND THE PRODUCTS DID NOT FUNCTION AS INTENDED. TWO REINFORCE METAL BLADES WERE ADDED TO THE CUTTERS AND ONE OF THE TWO BLADES FELL OFF AND SEPARATED FROM THE INSTRUMENTS ON TWO OCCASIONS. FRAGMENTS WERE RETRIEVED, NOTHING WAS LEFT IN THE PATIENT. ANOTHER CABLE CUTTER WAS USED TO COMPLETE THE PROCEDURE. NO SURGICAL DELAY OR PATIENT HARM WERE REPORTED. PATIENT OUTCOME WAS REPORTED STABLE. THE DEVICES WERE PREVIOUSLY USED. NO UNUSUAL USE OF THE DEVICES WERE REPORTED. CONCOMITANT DEVICES REPORTED: ZIPFIX (UNKNOWN PART AND LOT NUMBERS, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7341618 ↗
• MalfunctionMar 15, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  (B)(6) DOCUMENTED THE FOLLOWING: IT WAS REPORTED THAT TWO (2) CABLE CUTTERS BROKE DURING A PRIMARY STERNOTOMY PROCEDURE ON (B)(6) 2018. THE SURGEON WAS ATTEMPTING TO CUT A ZIPFIX WITH THE CABLE CUTTERS AND THE PRODUCTS DID NOT FUNCTION AS INTENDED. TWO REINFORCE METAL BLADES WERE ADDED TO THE CUTTERS AND ONE OF THE TWO BLADES FELL OFF AND SEPARATED FROM THE INSTRUMENTS ON TWO OCCASSIONS. FRAGMENTS WERE RETRIEVED, NOTHING WAS LEFT IN THE PATIENT. ANOTHER CABLE CUTTER WAS USED TO COMPLETE THE PROCEDURE. NO SURGICAL DELAY OR PATIENT HARM WERE REPORTED. PATIENT OUTCOME WAS REPORTED STABLE. THE DEVICES WERE PREVIOUSLY USED. NO UNUSUAL USE OF THE DEVICES WERE REPORTED. CONCOMITANT DEVICES REPORTED: ZIPFIX (UNKNOWN PART AND LOT NUMBERS, QUANTITY UNKNOWN) THIS COMPLAINT INVOLVES TWO DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7341615 ↗
• MalfunctionJun 30, 2017Break; Material Fragmentation; Break; Material Fragmentation

  ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 30, 2017 WITH FURTHER REPORTING THAT THE SURGEON WAS USING CABLE CUTTERS TO CUT AND SHORTEN A DEPUY 5.5MM TI ROD (PART # 1797-62-300). THE SURGEON HELD THE ROD OVER THE STERILE TABLE, ATTEMPTING TO CUT THE ROD WHEN THE CABLE CUTTER BROKE. THERE WERE NO FRAGMENTS FROM THE BROKEN CABLE CUTTER. THE BROKEN PIECE FROM THE CABLE CUTTER WAS RETRIEVED AND THE ROD WAS NOT AFFECTED. THERE WAS NO PATIENT IMPACT. IT WAS NOTED THAT THE INCORRECT CABLE CUTTERS WERE USED. THE SURGEON OBTAINED THE CORRECT CUTTER DESIGNED TO CUT RODS. THE SURGEON CUT THE ROD FOR THE PURPOSE OF MAKING IT SHORTER. IT IS UNKNOWN IF ANY ADDITIONAL HARDWARE WAS ADDED. ONLY ONE ROD WAS SHORTENED. THE REST OF THE DEPUY HARDWARE REMAINED INTACT. THE HARDWARE WAS ORIGINALLY IMPLANTED IN (B)(6) 2016 AND WAS REMOVED FROM THE C1-C2 LEVEL DUE TO BURSITIS. THE SURGEON COMPLETED THE PROCEDURE SUCCESSFULLY AND THE PATIENT WAS REPORTED AS STABLE. CONCOMITANT DEVICE REPORTED: DEPUY 5.5MM TI ROD (PART # 1797-62-300, LOT # UNKNOWN, QUANTITY OF 1).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6680351 ↗