MAUDE Adverse Event Report: STRYKER GMBH GUIDE WIRE HANDLE IMN INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	23510030
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
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
As reported: "our guide wire handle in our consigned im nailing basic tray is broken.It is not grabbing the wire like it should.".
Event or Problem Description
As reported: "our guide wire handle in our consigned im nailing basic tray is broken.It is not grabbing the wire like it should.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: one pin had come off from the metal clamping lever.Furthermore, evident signs of damage [hitting marks] were verified at the guide wire handle connection rod.Visual inspection revealed the drill hole, as the counterpart of missing pin, shows traces of intended press-fit.Thus, a dimensional inspection could not be performed safely.A review of the device history for the reported lot did not indicate any abnormalities.A review of the labelling did not indicate any abnormalities.Based on investigation of former complaints the event was identified being design related and is already covered by an nc / capa.Nc was filed and a capa triggered.Finally, it could also not be excluded that the obvious signs of hitting marks contributed to the event reported.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

• Brand Name: GUIDE WIRE HANDLE IMN INSTRUMENTS
• 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: 18123375
• Report Number: 0009610622-2023-00413
• Device Sequence Number: 7609418
• Product Code: LXH
• UDI-Device Identifier: 07613327361674
• UDI-Public: 07613327361674
• Combination Product (Y/N): N
• 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): 02/05/2024

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: 23510030
• Device Lot Number: KME914803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2020
• 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
• Patient Sex: Unknown