MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DELTA STRIKE PLATE IMN INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	23510050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2019
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 evaluated by mfr: device disposition unknown.
Event or Problem Description
As reported: "doctor was impacting the t2 alpha tibia nail over the ball-tip guide wire into the intramedullary canal of the patient's tibia.As doctor continued to impact the strike plate to advance the nail into its final position, the delta strike plate sheared off the nail adapter tibia spi.The threads of the delta strike plate remained engaged in the nail adapter tibia spi, and the breaking point appears to be at the junction of the strike plate threads and the strike plate shaft.Once the strike plate was broken, the surgeon held the broken strike plate in its intended position and finished impacting the nail to its final position.Thereafter, the case continued as normal and there was no harm done to the patient as a result of the breakage.There was nothing unusual in the technique the surgeon used to impact the nail including how hard they were hitting the strike plate.The instrumentation in question is new and i would estimate it to have been used/ sterilized less than 30 times.".
Event or Problem Description
As reported: "doctor was impacting the t2 alpha tibia nail over the ball-tip guide wire into the intramedullary canal of the patient's tibia.As doctor continued to impact the strike plate to advance the nail into its final position, the delta strike plate sheared off the nail adapter tibia spi.The threads of the delta strike plate remained engaged in the nail adapter tibia spi, and the breaking point appears to be at the junction of the strike plate threads and the strike plate shaft.Once the strike plate was broken, the surgeon held the broken strike plate in its intended position and finished impacting the nail to its final position.Thereafter, the case continued as normal and there was no harm done to the patient as a result of the breakage.There was nothing unusual in the technique the surgeon used to impact the nail including how hard they were hitting the strike plate.The instrumentation in question is new and i would estimate it to have been used/ sterilized less than 30 times.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device returned broke on the transition radii of the thread undercut to the stop shoulder of the thread connection.A microscope analysis of the surface of the device shows a brittle area, which proves that the material was subjected to a significant amount of stress, which led to its breakage without significant plastic deformation.This leads to the conclusion that this event was due to a user related root cause.The analysis of the device resulted in finding that the thread of the strike plate had been damaged by excessive load application resulting from incorrect engagement in the counterpart.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.If any further information is provided, the investigation report will be updated.

• Brand Name: DELTA STRIKE PLATE 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
• MDR Report Key: 8867812
• Report Number: 0009610622-2019-00609
• Device Sequence Number: 19466398
• Product Code: LXH
• UDI-Device Identifier: 07613327350210
• UDI-Public: 07613327350210
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/15/2019

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: 23510050
• Device Lot Number: KP423346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1