MAUDE Adverse Event Report: STRYKER GMBH RC LAG SCREW GAMMA4 Ø10.5X90MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81660090S
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
Intraoperatively, the sales rep was informed by phone that ¿when the u blade was tapped, the lag screw entered deeply into the pelvic direction".The sales rep instructed the surgeon to remove the lag screw and retry the procedure again.Finally, the surgery was finished.It was found that this was caused by an attempt to insert the u-blade with the lag screwdriver handle horizontal to the target device.As a result, the set screw was also not properly fixed, resulting in the lag screw being pushed inward.
Additional Manufacturer Narrative
Correction - please refer to h6 component code and health impact code.The reported event could not be confirmed due to the lack of evidence.Nonetheless, based on the information received, it could be determined that the root cause is user related, as hcp failed to properly follow the instructions of rc lag screw/u-blade insertion.Indeed, it has been communicated that it was found that this was caused by an attempt to insert the u-blade with the lag screwdriver handle horizontal to the target device.This is a clear deviation of the operative technique.As a reminder, the operative technique instructs that the lag screwdriver handle must be perpendicular (90°) to the targeting arm for a proper rc lag screw insertion and that the lag screwdriver must be removed from the setup prior to the u-blade insertion.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Intraoperatively, the sales rep was informed by phone that ¿when the u blade was tapped, the lag screw entered deeply into the pelvic direction".The sales rep instructed the surgeon to remove the lag screw and retry the procedure again.Finally, the surgery was finished.It was found that this was caused by an attempt to insert the u-blade with the lag screwdriver handle horizontal to the target device.As a result, the set screw was also not properly fixed, resulting in the lag screw being pushed inward.

• Brand Name: RC LAG SCREW GAMMA4 Ø10.5X90MM
• 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: 21009074
• Report Number: 0009610622-2024-00972
• Device Sequence Number: 9004383
• Product Code: HSB
• UDI-Device Identifier: 07613327591804
• UDI-Public: (01)07613327591804(17)340430(10)K1B9176
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K230512
• 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): 03/25/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 81660090S
• Device Lot Number: K1B9176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2024
• 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 Sex: Unknown