MAUDE Adverse Event Report: STRYKER TRAUMA KIEL STRIKE PLATE T2 FEMUR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
Distortion was found when the strike plate was removed after fixing the nail.When i watched it closely, there was a crack in the screw hole.Procedure was completed successfully with no surgical delay or adverse consequences reported.
Additional Manufacturer Narrative
Correction: concomitant medical products /device evaluated by mfr sample return cancelled.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.The batch record could not be reviewed because the affected device was not returned and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Distortion was found when the strike plate was removed after fixing the nail.When i watched it closely, there was a crack in the screw hole.Procedure was completed successfully with no surgical delay or adverse consequences reported.

• Brand Name: STRIKE PLATE T2 FEMUR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 9213370
• Report Number: 0009610622-2019-00870
• Device Sequence Number: 2423814
• Product Code: LXH
• UDI-Device Identifier: 04546540196088
• UDI-Public: 04546540196088
• Combination Product (Y/N): N
• 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): 12/20/2019

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: 18060150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1