MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3® Ø10.5X90MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3066-0090S

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problem Injury (2348)

Event Date 12/03/2019

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

As reported: "after treatment with a gamma nail for a cervical fracture, the lag screw excessively telescoped to a cutout.Surgeon think there is a possibility that the set screw did not fit into the lag screw." revision surgery occurred as a result.

Manufacturer Narrative

The reported event could be confirmed, since the device was returned, and x-rays were provided for evaluation and matches the alleged failure.The device inspection revealed the following: upon inspection of the received lag screw it was noticed there were no indentation marks of the set screw on any of the grooves.On the contrary, the set screw was initially placed on the outer surface of the lag screw just aside the groove, evident by a significant mark.This didn¿t let the lag screw to firmly secure with the nail.On account of this the lag screw started to move laterally, as evident by the x-rays.A tread mark along the middle region of the lag screw is indicative of the final position of the set screw.The mark being subsequently caused by set screw during explantation.The u-blade was also received, with one of its leg in a bent state.A functional inspection was performed by inserting the lag screw inside the nail to see whether it is adequately getting locked with the set screw or not.Upon assembly of the returned nail, set screw and the lag screw, it was found that the lag screw could be easily locked, even at different locations.Since the u-blade was bent, it couldn¿t be assembled.With the available patient details, a medical opinion was sought from our medical expert.To the given details he opined (excerpts): ¿the patient weighs 38kg¿.This value indicates a massive underweight-at least if the patient was not only 130cm high.So, she probably is pretty cachectic, meaning a poor nutrition status and thus a poor bone density.This can not be assessed only by x-ray, but the images suggest a poor bone density.The reduction is fair.In the ap-view a small gap can be identified at the lesser trochanter, and the ccd is surprisingly high-it seems to be reduced in a valgic position.¿ the x-rays provided depicts rotation of the femoral head inferiorly which was also supported by a small gap at the lesser trochanter.It was also opined by the medical expert that the patient had a pretty poor bone density.Consequently, the rotation of the femoral head post operatively, supported by patient¿s poor bone quality led to an easy cut-out of the lag screw in just over a months time.The mal-positioning of the set screw however didn¿t contribute to the cut-out, as it just allowed lateral movement of the lag screw during the cut-out.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the root cause of the failure is patient related.If any further information is provided, the complaint report will be updated.

Event Description

As reported: "after treatment with a gamma nail for a cervical fracture, the lag screw excessively telescoped to a cutout.Surgeon think there is a possibility that the set screw did not fit into the lag screw." revision surgery occurred as a result.

• Brand Name: U-BLADE SET, TI GAMMA3® Ø10.5X90MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9521816
• MDR Text Key: 178642385
• Report Number: 0009610622-2019-00990
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540595980
• UDI-Public: 04546540595980
• Combination Product (y/n): N
• PMA/PMN Number: K043431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3066-0090S
• Device Catalogue Number: 30660090S
• Device Lot Number: K071CF4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 38