MAUDE Adverse Event Report: STRYKER GMBH T2 - GUIDE WIRE, BALL-TIPPED, STERILE D3X1000 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060085S
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
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
The customer reported that: "27-year-old patient admitted to the emergency room for intramedullary nailing due to a fracture of the left tibia.During the reaming process, the guide rod became damaged and began to chip away at the tibial shaft." removal of the guide rod and replacement with a new rod (different batch).No consequences, no metal residue visually present in the surgical site.
Additional Manufacturer Narrative
Please note the correction to d9 as the device was not returned for evaluation.Please also note the correction to h6 device code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.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.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
The customer reported that : "27-year-old patient admitted to the emergency room for intramedullary nailing due to a fracture of the left tibia.During the reaming process, the guide rod became damaged and began to chip away at the tibial shaft." removal of the guide rod and replacement with a new rod (different batch).No consequences, no metal residue visually present in the surgical site.
Additional Manufacturer Narrative
Please note the corrections to d9, h6 method, h6 results and h6 conclusion codes.The reported event of chipped away material could be confirmed since the device returned was found to be obviously damaged.Detailed inspection revealed an evident bent guide wire and a significantly damaged surface.The wire presents chipped away material.This accumulation of material proved to be compacted and displaced, and scratches and grooves were visible in the immediate vicinity of the surface, which appeared to be circumferential.The root cause was already given with the event description ¿during the reaming process, the guide rod became damaged and began to chip away.The labelling clearly points out ¿only use an instrument for its intended purpose.Improper use of instruments might lead to loss in function or usage¿ always treat the instrument carefully to avoid surface damage or alterations to the geometry¿ based on above the event was caused by improper handling during procedure.In case of intended use such damage would not have occurred.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
The customer reported that : "27-year-old patient admitted to the emergency room for intramedullary nailing due to a fracture of the left tibia.During the reaming process, the guide rod became damaged and began to chip away at the tibial shaft." removal of the guide rod and replacement with a new rod (different batch).No consequences, no metal residue visually present in the surgical site.

• Brand Name: T2 - GUIDE WIRE, BALL-TIPPED, STERILE D3X1000 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: 22571004
• Report Number: 0008031020-2025-01298
• Device Sequence Number: 14432169
• Product Code: LXH
• UDI-Device Identifier: 04546540195937
• UDI-Public: (01)04546540195937(17)291231(10)K0FCC18
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2025

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: 18060085S
• Device Lot Number: K0FCC18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 09/17/2025; 10/29/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 10/15/2025; 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2025
• 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 Age: 27 YR
• Patient Sex: Unknown