MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL ADAPTER TIBIA T2 ALPHA? TIBIA; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23534103
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 intremedullary 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
This device is concomitant and did not contribute to the reported failure.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
Event or Problem Description
As reported: "during an intremedullary 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: NAIL ADAPTER TIBIA T2 ALPHA? TIBIA
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8958120
• Report Number: 0009610622-2019-00632
• Device Sequence Number: 2088055
• Product Code: HSB
• UDI-Device Identifier: 07613327357059
• UDI-Public: 07613327357059
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K191271
• 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): 10/17/2019

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: 23534103
• Device Lot Number: KME910923
• 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: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1