MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3® Ø10.5X105MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3066-0105S

Device Problem Material Twisted/Bent (2981)

Patient Problems Failure of Implant (1924); Hip Fracture (2349)

Event Date 09/21/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.

Event Description

As reported: cutout of proximal femoral restoration with gamma3 u-blade, u-blade is bent, removal difficult.

Manufacturer Narrative

Please note corrections to sections d2a, d2b, d9/h3; the device was returned, and h6 (method, results and conclusion codes).The reported event was confirmed based on the damages of returned units.Provided x-rays did not show alleged cut out.They presented the nail tip and a prosthesis.When returned the u-blade set was completely jammed in the proximal drill hole of the nail.The lag screw had become stuck at the inferior transition from thread to shaft.One ¿blade¿ of the u-blade ¿ in inferior position ¿ was embedded in the corresponding flute of the lag screw.The other one was bent in approx.45° towards superior and in similar manner towards the right (view from lateral).Inside the nail the ¿blade¿ was embedded in the lag screw¿s flute.The review of manufacturing documents revealed no deficiency.The product was according to specs when distributed.No nc/capa had been filed for the item in question.Potential cut-out had been considered in the risk management file.The labelling informs about protentional adverse effects.Considering the appearance of the stuck blade ¿ bent in different directions ¿ it was concluded the blade followed the turning movement of the femur head fragment during the process of cutting out.This in turn led to jam of the construct lag screw / u-blade as the u-blade could no longer follow the groove in the lag screw.The final attempt of pulling both lag screw and u-blade out of the nail remained without avail.With available information the root cause of cut-out was regarded to bone deficiencies which would be patient factors.In case more substantive information becomes available we reserve the right to re-open the investigation with root cause assessment.

Event Description

As reported: cutout of proximal femoral restoration with gamma3 u-blade, u-blade is bent, removal difficult.

• Brand Name: U-BLADE SET, TI GAMMA3® Ø10.5X105MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12647600
• MDR Text Key: 277099349
• Report Number: 0009610622-2021-00762
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540596017
• UDI-Public: 04546540596017
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K200869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3066-0105S
• Device Catalogue Number: 30660105S
• Device Lot Number: K0CDA10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization