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

Catalog Number	18060150
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2019
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
As reported: "during impaction of the gtn nail, the strike plate broke at the threading into two pieces.The threads became lodged inside of the threaded strike plate attachment site on the targeter.Slowed down surgery".Procedure was completed successfully with no adverse consequences reported.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: physical examination of the returned device showed the strike plate to be broken and the threaded part of it remained stuck in the target device and could not be removed.The returned instruments show significant traces of intense and frequent use.Hitting marks are visible at the surface of the strike plate.The breakage surfaces of the strike plate showed the typical structure of a brittle fracture due to a bending overload and signs of torsion forces.Based on the above facts the root cause of the reported event was not related to a deficiency of the device but was rather linked to an inadequate handling by the user.The appearance and the extent of the damage indicated that the event was related to an intra-operative damage of the devices caused by not properly screwing the strike plate into the target device (no frictional connection between both units), which most likely had led to the breakage of the thread.In case of intended use such damage would not have occurred.Also, the device had been in use for a long time (manufactured in 2013), therefore it can be safely said that it had fulfilled its tasks in former surgeries as intended.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "during impaction of the gtn nail, the strike plate broke at the threading into two pieces.The threads became lodged inside of the threaded strike plate attachment site on the targeter.Slowed down surgery".Procedure was completed successfully with 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: 8804974
• Report Number: 0009610622-2019-00550
• Device Sequence Number: 11451789
• Product Code: LXH
• UDI-Device Identifier: 04546540196088
• UDI-Public: 04546540196088
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/20/2019

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: K09F316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1