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 Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/13/2019
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
As reported: "primary procedure, right femur (t2 alpha gt).It was reported that the threads of the t2 strike plate (not t2 alpha) broke in the t2 alpha targeting arm.As it was not known if the threaded portion could be removed, the targeting arm was impacted directly.It was found the threaded portion could be removed, and a second strike plate was used.There was no apparent damage to the targeting arm." also reported: "surgery was completed successfully with an overall delay of approximately 5 minutes." no adverse consequences reported.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to be wear related.The failure was caused by extensive use of the device.Indeed, the device inspection revealed the following: physical examination of the returned device showed the strike plate to be broken and the threaded part.The breakage pattern has the caracteristic that a chunck of the material between two levels of threads has been chopped off creating a missing "window" of material.Under microscope, it can clearly be seen that the suface below the connected threads presents a crack.The crack could have been introduced as a result of the fatigue of the material after more than 8 years in use, especially if the device used to be toggeled once screwed in the targeting device.The analysis of the material at the surface of the broken threads shows multiple secondary fractures (cracks in the material), which are most probably due to the fatigue of the material under bending stresses.This could have induced pre-damage to the material which would have finally gave in because of torsional overload.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 any further information is provided, the investigation report will be updated.
Event or Problem Description
As reported: "primary procedure, right femur (t2 alpha gt).It was reported that the threads of the t2 strike plate (not t2 alpha) broke in the t2 alpha targeting arm.As it was not known if the threaded portion could be removed, the targeting arm was impacted directly.It was found the threaded portion could be removed, and a second strike plate was used.There was no apparent damage to the targeting arm." also reported: "surgery was completed successfully with an overall delay of approximately 5 minutes." no 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: 9288583
• Report Number: 0009610622-2019-00914
• Device Sequence Number: 2340780
• Product Code: LXH
• UDI-Device Identifier: 04546540196088
• UDI-Public: 04546540196088
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/13/2020

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 Catalogue Number: 18060150
• Device Lot Number: K415137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Initial Date Received by Manufacturer: 10/13/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1