MAUDE Adverse Event Report: STRYKER GMBH IMN INSTRUMENTS - FREEHAND DRILL D4.2X130MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	23514213S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
The customer reported that: "while washing the ancillary equipment in sterilization, the sterilization agent noticed that a piece was missing from the t2 alpha stryker drill ref 2351-4213s.Check the patient's x-ray, where you can see the piece of drill next to the screw.No reoperation in the operating room is necessary, according to the surgeon.Patient discharged on (b)(6) 2026 with no complications so far.No intervention to remove the tip is necessary at this time.".
Additional Manufacturer Narrative
Corrections: please refer to section h6 (method code).The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history was not possible because the reported lot number does not exist.No corrective actions are required at this time.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 was not communicated.As lot is unknown.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reported that: "while washing the ancillary equipment in sterilization, the sterilization agent noticed that a piece was missing from the t2 alpha stryker drill ref (b)(4).Check the patient's x-ray, where you can see the piece of drill next to the screw.No reoperation in the operating room is necessary, according to the surgeon.Patient discharged on (b)(6) 2026 with no complications so far.No intervention to remove the tip is necessary at this time.".

• Brand Name: IMN INSTRUMENTS - FREEHAND DRILL D4.2X130MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA GMBH; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24280477
• Report Number: 0008031020-2026-00131
• Device Sequence Number: 9862596
• Product Code: LXH
• UDI-Device Identifier: 07613327350289
• UDI-Public: 07613327350289
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: 23514213S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 26 YR
• Patient Sex: Male
• Patient Weight: 63 KG