MAUDE Adverse Event Report: STRYKER GMBH THREADED GUIDE WIRE ASNIS III Ø1.4X150MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	702459S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The returned threaded cannulated wire was found fractured at the distal end within the threaded section, approximately 30 mm from the tip.Examination of the fracture surface indicates a brittle failure mode, characterized by the absence of plastic deformation.The observed features suggest that the breakage was primarily caused by the application of excessive torsional overload during use.A dimensional inspection was conducted for the return device, and it was found to be within specification.A review of the device history was not possible because the lot number was not communicated.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.Based on the available information, the root cause can be attributed to user related as the breakage is brittle in nature caused by application high torsional load.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that, the drill broke during use leaving fragments inside the body.In addition to the drill, the guide wire also broke.No further information was provided.
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that, the drill broke during use leaving fragments inside the body.In addition to the drill, the guide wire also broke.No further information was provided.

• Brand Name: THREADED GUIDE WIRE ASNIS III Ø1.4X150MM
• 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: 23827725
• Report Number: 0008031020-2025-02166
• Device Sequence Number: 17413331
• Product Code: LXH
• UDI-Device Identifier: 04546540381996
• UDI-Public: 04546540381996
• 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): 02/18/2026

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: Lay User/Patient
• Device Catalogue Number: 702459S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/18/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male