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	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.
Event or Problem Description
During inserting the nail, the strike plate broke at the thread.A part of the thread remained in the target device.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on complaint history, some of the possible causes for the reported damage could be applying excessive force while hammering, incorrect connection of the strike plate with another corresponding instrument.The ifu addresses that the instruments shall be used for their intended usage, described in the operative technique.Furthermore, the instruments shall be inspected prior to every surgery and shall be handled with care to avoid damages.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
During inserting the nail, the strike plate broke at the thread.A part of the thread remained in the target device.

• 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: 8461803
• Report Number: 0009610622-2019-00129
• Device Sequence Number: 1962991
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

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: K570135
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other