MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA Ø8X285 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18220828S
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.
Event or Problem Description
The surgeon reported that he was undertaking a 2 stage revision of knee and decided to use a gamma nail as a spacer.During the case he inserted the nail and when he inserted one of the screws it was the wrong size.The screw was not fully seated and when the surgeon tried to remove it, it cold welded itself onto the nail.The surgeon left the nail and screw in situ.The reported event resulted in a 2 hour delay to surgery and the surgeon was concerned about the risk of infection due to the length of time the patient was on the table.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.Based on investigation, the root cause was attributed to a user related issue.The failure is most likely caused due to 5mm screw was used in a hole designed for a 4mm screw.The screw got stuck in the nail before it was fully seated.A review of the labeling did not indicate any abnormalities.No indications of 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
The surgeon reported that he was undertaking a 2 stage revision of knee and decided to use a gamma nail as a spacer.During the case he inserted the nail and when he inserted one of the screws it was the wrong size.The screw was not fully seated and when the surgeon tried to remove it, it cold welded itself onto the nail.The surgeon left the nail and screw in situ.The reported event resulted in a 2 hour delay to surgery and the surgeon was concerned about the risk of infection due to the length of time the patient was on the table.

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA Ø8X285 MM
• 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: 8337604
• Report Number: 0009610622-2019-00066
• Device Sequence Number: 10814726
• Product Code: HSB
• UDI-Device Identifier: 04546540197610
• UDI-Public: 04546540197610
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K003018
• 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): 04/26/2019

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 Expiration Date: 12/31/2022
• Device Catalogue Number: 18220828S
• Device Lot Number: K0DF76F
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other