MAGNUM OM-9020Recalls & reported problems
Smith & Nephew, Inc. · MAGNUM PUNCH (3.2MM) · Class 1
All models of MAGNUM (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00817470005967), received between Jun 17, 2018 and Oct 25, 2021 — classified as 2 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Break” (8 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 18, 2026.
Most reported problems
Device problems
- Break8
- Crack1
- Detachment Of Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Known Impact Or Consequence To Patient5
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryOct 25, 2021Break; Break
IT WAS REPORTED THAT, DURING SHOULDER ARTHROSCOPY, THE TOP PORTION OF THE "3.2MM MAGNUM PUNCH" BROKE INTO 2 PIECES, INSIDE OF THE PATIENT, WHEN THE SURGEON ATTEMPTED TO PULL IT OUT OF THE BONE. ALL PIECES WERE RECOVERED FROM THE PATIENT USING PLIERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12694465 ↗InjurySep 23, 2021Break
IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE AWL OF THE MGNUM PUNCH BROKE. THE AWL IS SHAPED LIKE A "T", AND AT THE JOINT OF THE SHAFT AND THE HANDLE, IT DID NOT LOOK LIKE IT IS WELDED TOGETHER. IT KEPT COMING APART AS THEY TRY TO PULL IT OUT OF THE JOINT/BONE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NO SURGICAL DELAY WAS REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12523400 ↗MalfunctionMay 19, 2021Break; Break
IT WAS REPORTED THAT, DURING USE IN AN ARTHROSCOPY, THE T HANDLE OF THE MGNUM PUNCH BROKE AS PULLING IT OUT OF HUMERAL HEAD. A DELAY LESS OR EQUAL THAN 30 MINUTES WERE REPORTED AND THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11851799 ↗MalfunctionMay 18, 2021Break; Break
IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE T HANDLE ON THE MAGNUM PUNCH SNAPPED OFF WHILST PULLING OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH NO PATIENT INJURY. A DELAY EQUAL TO OR LESS THAN 30 MINUTES WAS REPORTED. NO FURTHER COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11846490 ↗MalfunctionApr 7, 2021Break; Break
IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR THE MGNUM PUNCH'S HANDLE BROKE FROM THE SHAFT EXTERNALLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11632139 ↗MalfunctionFeb 5, 2019Break
IT WAS REPORTED THAT THE T-HANDLE BROKE FROM THE MAGNUM PUNCH. NO PATIENT INJURY WAS REPORTED. BACK-UP DEVICE WAS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8307521 ↗MalfunctionJan 17, 2019Break
IT WAS REPORTED THAT DURING PROCEDURE, T-HANDLE FROM MAGNUM PUNCH BROKE INSIDE THE PATIENT. THE SURGEON WAS HOLDING THE INSTRUMENT WHEN IT BROKE SO IT WAS REMOVED BY HAND. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8256271 ↗MalfunctionNov 23, 2018Crack
IT WAS REPORTED THAT DURING A PROCEDURE, WHEN TAPPING UNDERNEATH THE T-BAR THERE WAS A CRACK AND THE TOP CAME OFF FROM THE PUNCH. THE PUNCH WAS REMOVED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8099961 ↗MalfunctionNov 13, 2018Break
IT WAS REPORTED THAT THE HANDLE WAS REMOVED FROM BODY OF PUNCH - POOR SOLDER BETWEEN THE JOIN. PUNCH WAS TAPPED INTO PATIENT, HANDLE SNAPPED OFF ON REMOVAL, THE HANDLE HAD TO BE PULLED OUT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8063787 ↗MalfunctionJun 17, 2018Detachment Of Device Component
IT WAS REPORTED THAT THE HANDLE CAME OFF DURING THE CASE. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7608479 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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