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

Catalog Number	23534107
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2019
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: "while nail was being implanted it was pointed out the [t2 alpha tibial] targeting arm was broken.Case was completed.".
Additional Manufacturer Narrative
The reported event could be confirmed.Visual inspection: the item received showed no significant signs of damage in terms of mis-handling.The returned t2 alpha tibia target device showed a button being sunk into the into the target device.Incoming inspection and the dhr of the reported tibia target device revealed no manufacturing discrepancies.The spring plate of the button for release of inserted sleeves were broken.With view from the back a detailed visual examination revealed a broken spring plate.The component was broken at the connection area to the targeting arm and shows a slight curved breakage a review of the labeling did not indicate any abnormalities.A non-conformity was raised for this product issue.Based on the investigation, the root cause is related to a non-optimal gluing process.
Event or Problem Description
As reported: "while nail was being implanted it was pointed out the [t2 alpha tibial] targeting arm was broken.Case was completed.".

• Brand Name: TARGETING ARM 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: 9251726
• Report Number: 0009610622-2019-00899
• Device Sequence Number: 546623
• Product Code: HSB
• UDI-Device Identifier: 07613327357080
• UDI-Public: 07613327357080
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 01/08/2020

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: 23534107
• Device Lot Number: KME912457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR