MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 3/32 FEMORAL EYELOOP DRILL (BOX OF 6); BIT, DRILL

Catalog Number	234-020-023
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that the device broke during the procedure.All pieces were able to be retrieved.
Event or Problem Description
It was reported that the device broke during the procedure.All pieces were able to be retrieved.
Additional Manufacturer Narrative
Alleged failure: "drill tip snapped and was successfully removed, used other instrumentation to complete instead of the femoral eye loop drill.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be user excessive force.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: PKG, 3/32 FEMORAL EYELOOP DRILL (BOX OF 6)
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 19667667
• Report Number: 0002936485-2024-00493
• Device Sequence Number: 6745406
• Product Code: HTW
• UDI-Device Identifier: 34546540755415
• UDI-Public: 34546540755415
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• 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): 10/02/2024

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: 234-020-023
• Device Lot Number: 5454023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 10/02/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown