MAUDE Adverse Event Report: STRYKER GMBH CONDYLE SCREW T2 FEMUR Ø5X40 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18955040S
Medical Device Problem Codes	Break (1069); Fracture (1260); Off-Label Use (1494)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that due to the nail and condyle screw breaking, they were removed and replaced to gmrs.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned, and matches the alleged failure.The condyle screw was returned in broken condition.The breakage had occurred in the ground of the first winding of the connecting thread and the rest of the broken part was stuck into the condyle screw nut.Bright areas on the shaft of the screw were identified as bearing points with the drill hole of the nail.Visual inspection of the distal holes of the nail we can see the screw rubbing around the walls of the hole which also confirm the misalignment while drilling and screw placement.The breakage is in the fatigue manner.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on the above investigation and it can be ascertained that the breakage is in a fatigue manner, the root cause can be attributed to user related as t2 scn screws are used with gamma nail which is off-label.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that due to the nail and condyle screw breaking, they were removed and replaced to gmrs.

• Brand Name: CONDYLE SCREW T2 FEMUR Ø5X40 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18297558
• Report Number: 0009610622-2023-00445
• Device Sequence Number: 7358638
• Product Code: HSB
• UDI-Device Identifier: 04546540202116
• UDI-Public: 04546540202116
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

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: Lay User/Patient
• Device Catalogue Number: 18955040S
• Device Lot Number: K03509E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• 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
• Patient Sex: Male