MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT, AO DIA2.0MM X 135MM, SCALED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	703896
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information, the device will not be returned.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
It was reported via medwatch #mw5182803: "drill bit used in a joint of the foot.After use and examination, it was noted that the tip of the drill was broken.Drill bit was left in bone as attempting to remove it could cause more damage".No further information is available.
Event or Problem Description
It was reported via medwatch # mw5182803: "drill bit used in a joint of the foot.After use and examination, it was noted that the tip of the drill was broken.Drill bit was left in bone as attempting to remove it could cause more damage".No further information is available.
Additional Manufacturer Narrative
The reported event could not be confirmed since the affected device was not returned, and no other evidence was shared for evaluation.A device inspection was not possible since the affected device was not returned.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required currently.No indications of material, manufacturing or design-related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More information as well as the device affected must be available to determine the exact root cause of the issue.If the device is received or if any additional information is provided, the investigation will be reassessed.

• Brand Name: DRILL BIT, AO DIA2.0MM X 135MM, SCALED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24640819
• Report Number: 0008031020-2026-00428
• Device Sequence Number: 21281264
• Product Code: LXH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2026

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: 703896
• Device Lot Number: AR03BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Female