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

Catalog Number	23510050
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2019
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: "dr.Was impacting the t2 alpha gt nail, over the balltip guidewire, into the intramedullary canal of the patient's femur.As dr.Continued to impact the strike plate to advance the nail into its final position, he back-slapped the delta strike plate (2351-0050) to move the nail proximally.At this point, the delta strike plate sheared off the gt nail adapter.The threads of the delta strike plate remained engaged in the gt nail adapter, and the breaking point appears to be at the junction of the strike plate threads and the strike plate shaft.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, or the backslapping, including how hard they were hitting the strike plate." procedure was completed successfully with no adverse consequences or surgical delay reported.
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 lead to it breakage without significant plastic deformation.This leads us to conclude 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.
Event or Problem Description
As reported: "dr.Was impacting the t2 alpha gt nail, over the balltip guidewire, into the intramedullary canal of the patient's femur.As dr.Continued to impact the strike plate to advance the nail into its final position, he back-slapped the delta strike plate (2351-0050) to move the nail proximally.At this point, the delta strike plate sheared off the gt nail adapter.The threads of the delta strike plate remained engaged in the gt nail adapter, and the breaking point appears to be at the junction of the strike plate threads and the strike plate shaft.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, or the backslapping, including how hard they were hitting the strike plate." procedure was completed successfully with no adverse consequences or surgical delay reported.

• 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: 9153633
• Report Number: 0009610622-2019-00800
• Device Sequence Number: 11231028
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2019

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: 09/26/2019
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 11/29/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 8031020-11-27-2019-004R
• Patient Sequence Number: 1