MAUDE Adverse Event Report: STRYKER GMBH DRILL SLEEVE, LOCKING Ø3.1MM, SHORT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	705004
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "following drilling, the drill sleeve and drill became stuck.The procedure was successfully completed using a different drill and sleeve.".
Event or Problem Description
As reported: "following drilling, the drill sleeve and drill became stuck.The procedure was successfully completed using a different drill and sleeve.".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: drill bit and drill sleeve were received in stuck condition, however both the devices were separated from each other.After disassembly, the drill found damaged from where it was stuck.The area proximal to the flutes, and the flutes itself got deformed due to excess contact with the drill sleeve.The forefront of the drill is also deformed; it has become oval and especially at one location the material flows outwards from the ideal circular periphery which indicates that the drill drifted abnormally inside the drill sleeve in one direction during usage resulting in excess contact between drill bit and drill sleeve.Due to this excess contact, excess friction and heat was produced resulting in partial binding of both the instruments.A review of the device history was not possible because the lot number on the sleeve is not clearly visible due to damage.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number on the sleeve is not clearly visible due to damage.Based on investigation, the root cause was attributed to a user related issue.The event was caused due to misalignment of the drill inside drill sleeve during usage resulting in excess contact between drill bit and drill sleeve.If more information is provided, the case will be reassessed.

• Brand Name: DRILL SLEEVE, LOCKING Ø3.1MM, SHORT
• 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: 24028772
• Report Number: 0008031020-2026-00020
• Device Sequence Number: 9487482
• Product Code: LXH
• UDI-Device Identifier: 07613327083606
• UDI-Public: 07613327083606
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 03/31/2026

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: 705004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/31/2026
• 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