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

Model Number	2351-0030
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	08/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "primary procedure, left tibial nail.It was reported that upon impaction, a small piece (possibly a nut) fell off of the guide wire handle.The piece did not fall into the patient.The device was used to complete the procedure successfully with no surgical delay.Rep confirmed that no further information is available.
Additional Manufacturer Narrative
The reported event was confirmed.The received image revealed at least 1 pin had come off from the metal clamping lever.No part was returned for investigation.A product inspection could not be performed since no product was returned.A review of the device history could not be performed since no lot number was communicated.A review of the labelling did not indicate any abnormalities.Based on missing information an exact root cause could not be determined.
Event or Problem Description
As reported: "primary procedure, left tibial nail.It was reported that upon impaction, a small piece (possibly a nut) fell off of the guide wire handle.The piece did not fall into the patient.The device was used to complete the procedure successfully with no surgical delay.Rep confirmed that no further information is available.

• 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: 10576721
• Report Number: 0009610622-2020-00540
• Device Sequence Number: 14329492
• Product Code: LXH
• UDI-Device Identifier: 07613327361674
• UDI-Public: 07613327361674
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/01/2020

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1