MAUDE Adverse Event Report: STRYKER GMBH GUIDE WIRE, BALL-TIPPED, STERILE T2 Ø2.5X800 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060083S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported:"the surgeon asked for a slight bend in the guide, which ended broken in the ibode's fingers." another device was used to complete the procedure.
Event or Problem Description
As reported:"the surgeon asked for a slight bend in the guide, which ended broken in the ibode's fingers." another device was used to complete the procedure.
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was not returned.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 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.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
As reported:"the surgeon asked for a slight bend in the guide, which ended broken in the ibode's fingers." another device was used to complete the procedure.
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was returned and h6 (method, results and conclusion codes).The reported event could be confirmed based on the device inspection.The device inspection revealed the following: the device fractured into two pieces, with the second piece not returned.Additionally, the area near the fracture shows significant bending.The fracture surface appears smooth and uniform, without notable plastic deformation which is characteristic of a brittle fracture.Overall, the combination of bending and brittle fracture suggests the device was subjected to high lateral stress and excessive force during use, ultimately causing its failure.In addition, relevant dimensions were measured and are conforming to specifications.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 investigation, the root cause was attributed to a user-related issue.The event was caused by high lateral stress and excessive force applied during use.If more information is provided, the case will be reassessed.

• Brand Name: GUIDE WIRE, BALL-TIPPED, STERILE T2 Ø2.5X800 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; 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: 22003510
• Report Number: 0008031020-2025-00883
• Device Sequence Number: 21107115
• Product Code: LXH
• UDI-Device Identifier: 04546540195913
• UDI-Public: (01)04546540195913(17)291031(10)K1DA30C
• 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,Followup
• Report Date (Section B): 01/20/2026

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: 18060083S
• Device Lot Number: K1DA30C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 06/12/2025; 12/22/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 07/09/2025; 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown