MAUDE Adverse Event Report: TORNIER S.A.S. PERIPHERAL DRILL BIT DIA. 5.4MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	MWE200
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that items were identified as broken by the sales representative after the case during tray flipping.
Additional Manufacturer Narrative
Correction: h6.Device code.H11.Health code.D9.Product available to stryker.The reported event was confirmed, since the device was returned and matches the alleged failure mode.The device inspection revealed the following: a visual inspection of the returned device shows a slight bend in the straightness of the drill bit along with a chip of material missing along the flank at the cutting tip.Also present are chips of missing material and deformations along the edges of the land and flutes.A functional inspection was not possible as the returned instrument is visibly damaged rendering it non-functional.A dimensional inspection was not possible as a measurable feature of the device is damaged.However, during manufacturing, functionality test and dimensional inspection were done according to specifications.Based on investigation, the root cause was attributed to a user related issue.The instrument was damaged by the end user in a self-admitted incident in the operating room.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.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that items were identified as broken by the sales representative after the case during tray flipping.

• Brand Name: PERIPHERAL DRILL BIT DIA. 5.4MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23694289
• Report Number: 3000931034-2025-00667
• Device Sequence Number: 9193193
• Product Code: HWE
• UDI-Device Identifier: 03700386974090
• UDI-Public: (01)03700386974090(10)18B659
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: MWE200
• Device Lot Number: 18B659
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2018
• 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