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

Model Number	2351-0030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
When using the guide wire handle to insert the 3.2 x 1000 guide wire into the im canal of the femur, the doctor was using the mallet to insert the guide wire.When impacting the guide wire the pivot post that holds the handle together broke.All pieces were recovered, and there were no complications with the case.
Event or Problem Description
When using the guide wire handle to insert the 3.2 x 1000 guide wire into the im canal of the femur, the doctor was using the mallet to insert the guide wire.When impacting the guide wire the pivot post that holds the handle together broke.All pieces were recovered and there were no complications with the case.
Additional Manufacturer Narrative
Correction: refer to h6 device code.The reported event was confirmed.Visual inspection revealed 2 connecting pins had come off.The drill holes, as the counterparts of missing pins, showed 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.No corrective actions are required at this time.A review of the labelling did not indicate any abnormalities.Based on investigation an exact root cause could not be determined.

• Brand Name: GUIDE WIRE HANDLE IMN INSTRUMENTS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10838654
• Report Number: 0009610622-2020-00706
• Device Sequence Number: 2960215
• Product Code: LXH
• UDI-Device Identifier: 07613327361674
• UDI-Public: 07613327361674
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

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 Model Number: 2351-0030
• Device Catalogue Number: 23510030
• Device Lot Number: KME913369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1