MAUDE Adverse Event Report: STRYKER GMBH DRILL GUIDE D2.5MM, NON-LOCKING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	705022
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "the drill got stuck in the sleeve and broke.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was returned for evaluation and found to be functional in inspection.The returned drill guide was visually examined and showed light rubbing marks within the guide hole, consistent with the drill contacting the inner surface during use.Minor deformation was also observed at the tip of the guide teeth, likely resulting from routine use or handling of the device.A functional inspection was conducted with the return sleeve and a sample drill in which the drill could pass through the guide without any concerns, confirming the functionality of the device.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 the available information, the most probable root cause is user-related as device is functional in inspection.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "the drill got stuck in the sleeve and broke.".

• Brand Name: DRILL GUIDE D2.5MM, NON-LOCKING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24235211
• Report Number: 0008031020-2026-00110
• Device Sequence Number: 8981249
• Product Code: LXH
• UDI-Device Identifier: 07613327083491
• UDI-Public: (01)07613327083491(11)160125(10)K081A48
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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: 705022
• Device Lot Number: K081A48
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2016
• 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