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 Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2019
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
The customer reported that during a case involving the t2 alpha kit, the nail strike plate threads broke off within the nail jig making it extremely difficult to advance the nail down.All threads broke off within the outer jig, nothing fell into the patient.The case was completed using another instrument to push down the connecting bolt and advance the nail.There was a surgical delay of 5-10 minutes.
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 targeting 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.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device disposition unknown.
Event or Problem Description
The customer reported that during a case involving the t2 alpha kit, the nail strike plate threads broke off within the nail jig making it extremely difficult to advance the nail down.All threads broke off within the outer jig, nothing fell into the patient.The case was completed using another instrument to push down the connecting bolt and advance the nail.There was a surgical delay of 5-10 minutes.
Event or Problem Description
The customer reported that during a case involving the t2 alpha kit, the nail strike plate threads broke off within the nail jig making it extremely difficult to advance the nail down.All threads broke off within the outer jig, nothing fell into the patient.The case was completed using another instrument to push down the connecting bolt and advance the nail.There was a surgical delay of 5-10 minutes.
Additional Manufacturer Narrative
The reported event could be confirmed, since a piece of the thread of a strike plate could be found in the targeting device.The returned devices consisted of a targeting device and two delta strike plates with the reported catalog number and lot number.However, none of the two returned delta strike plates are broken.Indeed, the two are perfectly functional and their threads are not deformed/ damaged.Nonetheless, after checking the returned targeting device, it was discovered that the tip of a strike plate is indeed stuck inside of it.This means that a breakage of some strike plate indeed occurred.It was not possible to extract the tip for further analysis.Therefore, the reported event could be confirmed, but more detailed information about the complaint event as well as the real affected device must be available in order to determine the root cause.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, or during the backslapping of the device.- the application of a force while the device is not properly aligned with the targeting 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.If the rest of the device is returned or if any additional information is provided, the investigation will be reassessed.

• 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: 8909752
• Report Number: 0009610622-2019-00616
• Device Sequence Number: 13975283
• Product Code: LXH
• UDI-Device Identifier: 07613327350210
• UDI-Public: 07613327350210
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2020

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: KP423347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 09/19/2019; 12/17/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 10/16/2019; 01/13/2020
• 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