MAUDE Adverse Event Report: STRYKER GMBH U-BLADE LAG SCREWDRIVER GAMMA3®; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1320-0310
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/19/2023
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: "during insertion of the u-lag screw, the neck angle of the target device was incorrectly set and the screw got stuck in the nail, preventing the driver from turning.When the screwdriver is turned by force, two protrusions on the tip of the screwdriver are twisted off.One of the two fragments was not found.The procedure was switched to a regular lag screw, and the surgery was completed without any other problems.".
Event or Problem Description
As reported: "during insertion of the u-lag screw, the neck angle of the target device was incorrectly set and the screw got stuck in the nail, preventing the driver from turning.When the screwdriver is turned by force, two protrusions on the tip of the screwdriver are twisted off.One of the two fragments was not found.The procedure was switched to a regular lag screw, and the surgery was completed without any other problems.".
Additional Manufacturer Narrative
Correction - please refer to d3 manufacturer entity.The reported event could be confirmed since the device was returned and matches the alleged failure.Device inspection revealed the following: the received u-blade lag screwdriver was returned for investigation, in which we can clearly see that both of the pegs for u-blade connection are completely broken off.Additional damages on the threads of the threaded rod prevent further use.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 user related.If any additional information is provided, the investigation will be reassessed.

• Brand Name: U-BLADE LAG SCREWDRIVER GAMMA3®
• 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: 16740343
• Report Number: 0009610622-2023-00118
• Device Sequence Number: 12473366
• Product Code: HSB
• UDI-Device Identifier: 04546540377845
• UDI-Public: 04546540377845
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032244
• 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): 06/27/2023

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: 1320-0310
• Device Catalogue Number: 13200310
• Device Lot Number: K0BA2FC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/19/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female