MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X30 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18965030S

Device Problems Entrapment of Device (1212); Inadequacy of Device Shape and/or Size (1583); Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

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 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 additional information received from the rep.Indicated that the issue was with the tibial nail (18220828s) and the locking screw that was used with it: i am not sure exactly which screw it was, as i wasn¿t in the theatre when it was implanted, but on the patients implant sheet, the 5x30mm screw (1896-5030s) is directly under the tibial nail and drill, so is most likely to be the screw that got stuck, as it was the first screw that they did that got stuck.The case that the implants were being used in, was a 2 stage revision knee.This involved removing the in situ implants and bone resection, washing out the joint space, putting a spacer in to preserve the joint space, and then closing the wound.In this case, as there was considerable bone resection on both the tibia and the femur, the surgeon decided to use a tibial nail in the tibial (locked distally) and a supracondylar nail in the femur (locked proximally), and the proximal end of the tibial nail and the distal end of the supracondylar nail were secured together in cement in the joint space.The issue was only with the distal screw in the tibial nail¿everything else went as the surgeon had planned.

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 additional information received from the rep.Indicated that the issue was with the tibial nail (18220828s) and the locking screw that was used with it.I am not sure exactly which screw it was, as i wasn¿t in the theatre when it was implanted, but on the patient's implant sheet, the 5x30mm screw (1896-5030s) is directly under the tibial nail and drill, so is most likely to be the screw that got stuck, as it was the first screw that they did that got stuck.The case that the implants were being used in, was a 2 stage revision knee.This involved removing the in situ implants and bone resection, washing out the joint space, putting a spacer in to preserve the joint space, and then closing the wound.In this case, as there was considerable bone resection on both the tibia and the femur, the surgeon decided to use a tibial nail in the tibial (locked distally) and a supracondylar nail in the femur (locked proximally), and the proximal end of the tibial nail and the distal end of the supracondylar nail were secured together in cement in the joint space.The issue was only with the distal screw in the tibial nail¿everything else went as the surgeon had planned.

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 a 5mm screw being 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.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X30 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: 8405185
• MDR Text Key: 138779910
• Report Number: 0009610622-2019-00099
• Device Sequence Number: 0
• Product Code: HSB
• 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 a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 18965030S
• Device Lot Number: K075463
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/08/2019
• 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