MAUDE Adverse Event Report: STRYKER GMBH GUIDE WIRE WITH RULER TUBE IMN INSTRUMENTS Ø3X1000 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	23513100S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "t2 alpha guidewire measuring tube metal cap debonded in patient¿s leg and had to be removed with forceps.No replacement item was used.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "t2 alpha guidewire measuring tube metal cap debonded in patient¿s leg and had to be removed with forceps.No replacement item was used.".
Additional Manufacturer Narrative
Please note the correction to b1, h1 and h6 health impact code.The report has been downgraded from si to reportable malfunction to be consistent with actual and potential severity.

• Brand Name: GUIDE WIRE WITH RULER TUBE IMN INSTRUMENTS Ø3X1000 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18675017
• Report Number: 0009610622-2024-00060
• Device Sequence Number: 6155647
• Product Code: LXH
• UDI-Device Identifier: 07613327361803
• UDI-Public: 07613327361803
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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: 23513100S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Sex: Unknown