MAUDE Adverse Event Report: TORNIER INC PERFORM SLAP HAMMER; EXTRACTOR

Catalog Number	MWM066
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during stem removal, the screw at the tip of the slap hammer broke.No further information was provided.
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that, during stem removal, the screw at the tip of the slap hammer broke.No further information was provided.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged event.The device inspection revealed the following.A detailed visual inspection of the returned device indicates extensive usage, evident from its dull surface appearance.The device is fractured at the threaded tip of the connector.The fracture surface displays shiny and granular characteristics, suggesting that bending occurred prior to the final break.The fracture pattern of the surface indicates a brittle nature of fracture.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing, or design-related problems were found during the investigation.Based on the investigation, the root cause was attributed to a combination of user-related factors and normal wear associated with repeated mechanical loading and sterilization, leading to cumulative damage over time.If any further information is provided, the investigation report will be reassessed.

• Brand Name: PERFORM SLAP HAMMER
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23829829
• Report Number: 0001649390-2025-00951
• Device Sequence Number: 13080873
• Product Code: HWB
• UDI-Device Identifier: 00846832082896
• UDI-Public: 00846832082896
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MWM066
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 48 KG