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

Catalog Number	23510050
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/08/2019
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 disposition unknown.
Event or Problem Description
It was reported that, while utilizing t2 alpha tibia nailing system, the strike plate was tightly fastened to the spi nail adapter, and after the strike plate experienced multiple hard blows from the slotted mallet, the strike plate broke.User backed the nail out to find that hard cortical bone from the fracture had fallen into the path of the nail, thus making it hard for the nail to seat to its final destination.Procedure was completed successfully and no adverse consequences or surgical delay were reported.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on complaint history review, one of the most probable root causes is, but is not limited to: a forced fracture of the material due to the application of an excessive force on the device.The application of a force while the device is not properly aligned with the tagerting arm.An improper engagement between the delta strike plate and the targeting arm, which could have caused the breakage of the delta strike plate at the threaded area.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that, while utilizing t2 alpha tibia nailing system, the strike plate was tightly fastened to the spi nail adapter, and after the strike plate experienced multiple hard blows from the slotted mallet, the strike plate broke.User backed the nail out to find that hard cortical bone from the fracture had fallen into the path of the nail, thus making it hard for the nail to seat to its final destination.Procedure was completed successfully and no adverse consequences or surgical delay were 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: 8752670
• Report Number: 0009610622-2019-00526
• Device Sequence Number: 2296822
• Product Code: LXH
• UDI-Device Identifier: 07613327350210
• UDI-Public: 07613327350210
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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): 10/11/2019

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?: No
• Initial Date Received by Manufacturer: 06/08/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR