MAUDE Adverse Event Report: STRYKER TRAUMA KIEL CONDYLE SCREW T2 FEMUR Ø5X75 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1895-5075S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after nail insertion, a condyle screw was inserted, but it did not engage with the nut at all.Once the surgeon tried to engage them outside the body, but it still didn't engage.Another screw was used to complete the surgery.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that after nail insertion, a condyle screw was inserted, but it did not engage with the nut at all.Once the surgeon tried to engage them outside the body, but it still didn't engage.Another screw was used to complete the surgery.
Additional Manufacturer Narrative
Please note correction to d4 lot #.The reported event could be confirmed.The device inspection revealed the following: the identification of the returned device was confirmed based on the catalog # and the lot# marked.The condyle screw shows signs of usage evident by intense scratches on the shaft.This may indicate that the insertion and/or extraction of the screw required great amount of force, possibly caused due to misalignment, consequently interacting with the nail and the washer.The threads are heavily damaged and are flattened in some parts, with faded anodization, which also indicates the fact that the screw was not inserted properly and was rather misaligned, thus damaging the screw when trying to engage it with the nut.The damaged and flattened threads also explain why the screw did not engage the nut when tested outside the patient's body.Therefore, the complaint was confirmed and the functionality of the device cannot be given anymore.During manufacturing, functionality test and dimensional inspection were done according to specifications.During the inspection, all devices met the specifications.Based on investigation, the root cause was attributed to an user related issue.The failure was caused by the misalignment of the inserted screw, which led to heavy damages on the threads when trying to engage the device with the nut.As a reminder, the instructions for use clearly state that: " during the course of the operation, repeatedly check to ensure that the connection between the implant and the instrument, or between the instruments, required for precise positioning and fixing is secure.Implants which consist of several components must only be used in the prescribed combination (see operative technique).After the procedure check the proper positioning of all implants using the image intensifier." 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.If more information is provided, the case will be reassessed.

• Brand Name: CONDYLE SCREW T2 FEMUR Ø5X75 MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15469646
• Report Number: 0009610622-2022-00440
• Device Sequence Number: 2892074
• Product Code: HSB
• UDI-Device Identifier: 04546540202185
• UDI-Public: 04546540202185
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203819
• 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): 11/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1895-5075S
• Device Catalogue Number: 18955075S
• Device Lot Number: K08EFB0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 11/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2022
• 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
• Patient Sex: Unknown