MAUDE Adverse Event Report: STRYKER GMBH LAG SCREW, TI GAMMA3 Ø10.5X105MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	30600105S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported" that during primary surgery surgeon inserted a gamma3 nail in a patient 4 weeks ago and the screw for locking the carrier, but the screw could not be turned forward.As the fracture was in a good position, surgeon decided not to replace it.Unfortunately, the carrier screw has now moved laterally, and he had to replace the nail after all.The initial surgery was on (b)(6) 2024, the revision surgery took place on (b)(6) 2024 where he inserted a new gamma3 nail.He did not want to extend the initial surgery on an (b)(6) year-old patient.Surgeon thinks that this is a dynamic system and that the screw should prevent rotation.However, it is still possible for the support screw to migrate up to approx.40% of the length of the screw.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Despite the return of the screw, the reported event could not be confirmed during the investigation.The device inspection revealed the following: the identification of the returned lag screw could be confirmed based on the catalog # and the lot # marked.The threads at the tip on the implant are deformed and worn out.Multiple parallel wear marks on the implant's shaft can be observed.Such marks are a result of friction between the screw and the lag screw hole during screw insertion and do not give any evidence of the reported migration.The extent of the deformation on the lag screw tip is unusual and could indicate a migration of the implant.However, the deformation alone does not give enough evidence to confirm the reported event.X-rays would have been essential in order to perform a complete investigation and confirm the implant migration.However, the images were not received.Nonetheless, based on the information provided, it could be determined that the alleged event is related to a user related issue.Indeed, it was confirmed by the user that the nail was implanted without the set screw.As a reminder, the use of the set screw is mandatory and ensures the stability of the set screw, its absence may lead to an implant migration.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.
Event or Problem Description
It was reported" that during primary surgery surgeon inserted a gamma3 nail in a patient 4 weeks ago and the screw for locking the carrier, but the screw could not be turned forward.As the fracture was in a good position, surgeon decided not to replace it.Unfortunately, the carrier screw has now moved laterally, and he had to replace the nail after all.The initial surgery was on (b)(6) 2024, the revision surgery took place on (b)(6) 2024 where he inserted a new gamma3 nail.He did not want to extend the initial surgery on an (b)(6) patient.Surgeon thinks that this is a dynamic system and that the screw should prevent rotation.However, it is still possible for the support screw to migrate up to approx.40% of the length of the screw.".

• Brand Name: LAG SCREW, TI GAMMA3 Ø10.5X105MM
• 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: 21072623
• Report Number: 0008031020-2025-00002
• Device Sequence Number: 8307394
• Product Code: HSB
• UDI-Device Identifier: 04546540374950
• UDI-Public: (01)04546540374950(17)290430(10)K1B9F18
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

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 Catalogue Number: 30600105S
• Device Lot Number: UNKNOWN
• 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: 12/08/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Unknown