MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ASSY. PKG TWINLOOP FLEX DRILL; BIT, DRILL

Catalog Number	3910-400-100
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient undergoing arthroscopic shoulder surgery experienced a broken drill bit which remained lodged intraosseously.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Additional Manufacturer Narrative
The device was not returned for investigation.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: broken drill bit.Probable root cause: application.-excessive force while drilling.-selection of wrong drill.-reuse of disposable drill.-use of reusable drill past lifetime.-starting and stopping drill.-pulling drill out of bone without running drill.-moving drill guide during drilling.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that a patient undergoing arthroscopic shoulder surgery experienced a broken drill bit which remained lodged intraosseously.
Event or Problem Description
It was reported that a patient undergoing arthroscopic shoulder surgery experienced a broken drill bit which remained lodged intraosseously.
Additional Manufacturer Narrative
Three attempts have been made to retrieve the device for evaluation, and it is yet to be received in-house.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: broken drill bit.Probable root cause: application: -excessive force while drilling, -selection of wrong drill, -reuse of disposable drill, -use of reusable drill past lifetime, -starting and stopping drill, -pulling drill out of bone without running drill, -moving drill guide during drilling.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: ASSY. PKG TWINLOOP FLEX DRILL
• 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 23382281
• Report Number: 0002936485-2025-00890
• Device Sequence Number: 18331097
• Product Code: HTW
• UDI-Device Identifier: 34546540678226
• UDI-Public: 34546540678226
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3910-400-100
• Device Lot Number: 22179AG2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 12/26/2025; 01/28/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 01/08/2026; 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Male
• Patient Weight: 70 KG