MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965040S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 evaluated by mfr: 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 e 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
This device is concomitant and did not contribute to the reported failure.If any additional information is provided indicating otherwise the investigation will be updated accordingly and a supplemental report will be provided.
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 e 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: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 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: 8337608
• Report Number: 0009610622-2019-00067
• Device Sequence Number: 10808792
• Product Code: HSB
• UDI-Device Identifier: 04546540202499
• UDI-Public: 04546540202499
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K032244
• 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): 04/22/2019

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: Lay User/Patient
• Device Catalogue Number: 18965040S
• Device Lot Number: K08F2C2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 04/22/2019
• 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