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	04/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Our product manager reported: "during a surgery at (b)(6) hospital in (b)(6) with the new t2 alpha tibia nail, there was an issue with the connection of the delta strike plate with the nail adapter tibia spi and we have below the specific comment from [surgeon] added in the eps form: thread of the delta strike plate is too short: broke with slight hammer blows." no issue with the surgery in terms of timing and final result.
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 breaking 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.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
Our product manager reported: "during a surgery at (b)(6) with the new t2 alpha tibia nail, there was an issue with the connection of the delta strike plate with the nail adapter tibia spi and we have below the specific comment from [surgeon] added in the eps form: thread of the delta strike plate is too short: broke with slight hammer blows" no issue with the surgery in terms of timing and final result.

• 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: 8716088
• Report Number: 0009610622-2019-00495
• Device Sequence Number: 1729103
• Product Code: LXH
• UDI-Device Identifier: 07613327350210
• UDI-Public: 07613327350210
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

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: KP423345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1