MAUDE Adverse Event Report: STRYKER GMBH RC LAG SCREW GAMMA4 Ø10.5X80MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81660080S
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: using the gamma4 u-lag screw 80 mm, the surgeon inserted the u-pin as usual and attempted to insert the u-lag end cap, but it was not inserted properly.Several attempts were made to insert the u-lag end cap while pushing in different directions, but it was not inserted properly.The insertion of the end cap was given up and distal fixation was performed.After checking the threading of the end cap and confirming the wear of the threads, another u-lag screw was opened, the end cap was replaced.The end cap was successfully installed and the procedure was completed.
Additional Manufacturer Narrative
Correction - please refer to h6 health impact code.The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.The returned end cap screw is found having deformed threads, mainly the first three to four threads are extremely deformed indicating application of excess torsional force.Minor dent marks and scratches were also seen on the upper threads, head and the shaft of screw which indicates excess metallic contact potentially due to hammering.All these observations suggest that probably the screw was misaligned during insertion, due to misalignment it although got inserted up to three to four threads but got stuck after that.On application of excess forces, the engaged threads got deformed and misaligned threads, head & shaft portion got scratch marks due to excess metallic contact.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 investigation, the root cause was attributed to be user related.The event was caused by the application of excess torsional force and hammering while misalignment of the end cap screw inside the mating part during usage.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: using the gamma4 u-lag screw 80mm, the surgeon inserted the u-pin as usual and attempted to insert the u-lag end cap, but it was not inserted properly.Several attempts were made to insert the u-lag end cap while pushing in different directions, but it was not inserted properly.The insertion of the end cap was given up and distal fixation was performed.After checking the threading of the end cap and confirming the wear of the threads, another u-lag screw was opened, the end cap was replaced.The end cap was successfully installed and the procedure was completed.

• Brand Name: RC LAG SCREW GAMMA4 Ø10.5X80MM
• 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: 20859682
• Report Number: 0009610622-2024-00942
• Device Sequence Number: 19848241
• Product Code: HSB
• UDI-Device Identifier: 07613327591729
• UDI-Public: (01)07613327591729(11)240826(17)340731(10)K1CFDEE
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K230512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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
• Device Catalogue Number: 81660080S
• Device Lot Number: K1CFDEE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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: Female