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

Model Number	2351-0050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2020
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: "t2 alpha tibia spi operation.After reaming during the sleeve the surgeon didn¿t remove the inner metal sleeve before trying to insert the tibia nail.He hammered on the strike plate to insert the nail.When discovering that there were not room for inserting the nail through the sleeve he back slashed.The delta strike plate broke at the threads and the distal part couldn¿t be removed.After removing the metal inner sleeve the nail were placed correctly".
Event or Problem Description
As reported: "t2 alpha tibia spi operation.After reaming during the sleeve the surgeon didn¿t remove the inner metal sleeve before trying to insert the tibia nail.He hammered on the strike plate to insert the nail.When discovering that there were not room for inserting the nail through the sleeve he back slashed.The delta strike plate broke at the threads and the distal part couldn¿t be removed.After removing the metal inner sleeve the nail were placed correctly.".
Additional Manufacturer Narrative
The reported event was confirmed.The device returned broke on the transition radii of the thread undercut to the stop shoulder of the thread connection in a brittle manner, which proves that the material was subjected to a significant amount of undue stresses.A review of the device history for the reported lot did not indicate any abnormalities.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.With available information the event was not linked to a deficiency of the device.Above scenario was classified being user related.

• 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; DE D-24232
• MDR Report Key: 9832778
• Report Number: 0009610622-2020-00108
• Device Sequence Number: 3029492
• Product Code: LXH
• UDI-Device Identifier: 07613327350210
• UDI-Public: 07613327350210
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2351-0050
• Device Catalogue Number: 23510050
• Device Lot Number: KP423345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 03/14/2020
• Supplement Report FDA Received Date: 06/15/2020
• 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