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

Model Number	3066-0105S
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Failure of Implant (1924); Hip Fracture (2349)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: cutout of proximal femoral restoration with gamma3 u-blade, u-blade is bent, removal difficult.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0009610622-2021-00762
• Device Sequence Number: 4713409
• Product Code: HSB
• UDI-Device Identifier: 04546540596017
• UDI-Public: 04546540596017
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K200869
• 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): 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown