MAUDE Adverse Event Report: TORNIER INC PERFORM REVERSED CENTRAL SCREWDRILL 6.5MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	MWJ111
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported during inbound inspection following a primary surgery that a 6.5mm central screw drill tip was broken.There was no reported presence of hard bone or debris.The screw drill had been in service for over five years.The device was inspected prior to being sent to the customer.A tracking number was provided for its return to the manufacturer.
Additional Manufacturer Narrative
Correction to d4 (gtin), g1 (reporting contact), and h3 (device evaluated by mfg).The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: a visual inspection revealed clear signs of breakage at the tip of the device, particularly around the fins of the drill.Additionally, multiple scratches and discoloration on the body suggest prolonged and heavy use.The transverse breakage pattern indicates that non-axial force was applied during use, exceeding the material's yield strength, which ultimately caused the breakage.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 investigation, the root cause was attributed to a wear and user related issue.The event was caused by heavy usage over prolong duration in service and application of non-axial forces leads to breakage.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported during inbound inspection following a primary surgery that a 6.5mm central screw drill tip was broken.There was no reported presence of hard bone or debris.The screw drill had been in service for over five years.The device was inspected prior to being sent to the customer.A tracking number was provided for its return to the manufacturer.

• Brand Name: PERFORM REVERSED CENTRAL SCREWDRILL 6.5MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21412889
• Report Number: 0001649390-2025-00097
• Device Sequence Number: 21196185
• Product Code: HWE
• UDI-Device Identifier: 00846832062348
• UDI-Public: (01)00846832062348(11)180716(10)BA0118004
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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: Other
• Device Catalogue Number: MWJ111
• Device Lot Number: BA0118004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown