MAUDE Adverse Event Report: STRYKER GMBH GUIDE WIRE, BALL-TIPPED, STERILE T2 Ø3X1000 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060085S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported that : "during reaming for a femur nail, the nail guide broke off sharply after few seconds of reaming.Clinical consequences and current status of the patient or person involved: serious consequences, increased duration of intervention, ++ risk of infection" 4/16/2025 - additional information received from the customer: the procedure could be completed correctly with another guide.Major consequences for the child: large additional incision (need for a large additional skin incision to remove the guide), increased block time, ++ risk of infection.
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was not returned.The reported event could be confirmed during the investigation.The device has not been returned for investigation.A photo of the broken guide wire was received, confirming the reported event.However, it was not possible to identify the lot number and no detailed investigation was possible based on the photo only.It was not possible to determine the root cause of the breakage without the device.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.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 : "during reaming for a femur nail, the nail guide broke off sharply after few seconds of reaming.Clinical consequences and current status of the patient or person involved: serious consequences, increased duration of intervention, ++ risk of infection" 4/16/2025 - additional information received from the customer: the procedure could be completed correctly with another guide.Major consequences for the child: large additional incision (need for a large additional skin incision to remove the guide), increased block time, ++ risk of infection.
Additional Manufacturer Narrative
Corrections: please refer to sections d9 the device was returned, and h6 (method, results and conclusion codes).The reported event could be confirmed during the investigation.The device inspection revealed the following: the identification of the returned guide wire was confirmed based on the catalog # and lot # marked.The instrument broke into three parts, all were returned.In addition to the breakage, the guide wire is heavily deformed and is heavily scratched.The surface of the broken areas, combined with the deformation observed, give evidence that the device broke in a ductile manner, as a result of continuous heavy bending load.Dimensional inspection confirmed that the device is within specification.Based on investigation, the root cause was attributed to an user related issue.The breakage was caused by heavy continuous bending load applied by the user.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.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: "during reaming for a femur nail, the nail guide broke off sharply after few seconds of reaming.Clinical consequences and current status of the patient or person involved: serious consequences, increased duration of intervention, risk of infection" 4/16/2025 - additional information received from the customer: the procedure could be completed correctly with another guide.Major consequences for the child: large additional incision (need for a large additional skin incision to remove the guide), increased block time, risk of infection.

• Brand Name: GUIDE WIRE, BALL-TIPPED, STERILE T2 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21924665
• Report Number: 0008031020-2025-00769
• Device Sequence Number: 8821905
• Product Code: LXH
• UDI-Device Identifier: 04546540195937
• UDI-Public: (01)04546540195937(17)280930(10)K18457B
• 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): 09/10/2025

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: 18060085S
• Device Lot Number: K18457B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 05/20/2025; 08/14/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/17/2025; 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown