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	08/08/2019
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: "during an intermedullary nail case, the strike plate was stripped out of the nail adapter completely while attempting to backslap a nail out.A second strike plate was then used in order to re-insert the nail and this strike plate also failed.Neither the nail adapter or strike plates were viable and we had to resort to using the older t2 system.This delayed the case and also ended up in wasting the first nail".
Additional Manufacturer Narrative
The reported event could be confirmed.The returned device has stripped threads, but is not broken.The threads are highly deformed and completely flattened, which causes the impossibility to connect the device with the targeting device anymore.This could be due to an improper connection between the delta strike plate and the targeting device, or the application of the force on the delta strike plate using an angle ( improper alignment between the two tools).This leads us to conclude that this event was due to a user related root cause.However, in order to avoid this kind of breakages in the future, and nc was opened to further optimize the design of the device.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: "during an intermedullary nail case, the strike plate was stripped out of the nail adapter completely while attempting to backslap a nail out.A second strike plate was then used in order to re-insert the nail and this strike plate also failed.Neither the nail adapter or strike plates were viable and we had to resort to using the older t2 system.This delayed the case and also ended up in wasting the first nail".

• 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: 8958122
• Report Number: 0009610622-2019-00635
• Device Sequence Number: 19479249
• Product Code: LXH
• UDI-Device Identifier: 07613327350210
• UDI-Public: 07613327350210
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/16/2019

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: KP423129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1