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

Catalog Number 18965040S

Device Problems Difficult to Remove (1528); Inadequacy of Device Shape and/or Size (1583); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2019

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 139213713
• Report Number: 0009610622-2019-00067
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540202499
• UDI-Public: 04546540202499
• Combination Product (y/n): N
• PMA/PMN Number: K032244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 18965040S
• Device Lot Number: K08F2C2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/16/2019
• Initial Date FDA Received: 02/13/2019
• Supplement Dates Manufacturer Received: 04/02/2019
• Supplement Dates FDA Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other