MAUDE Adverse Event Report: STRYKER GMBH LAG SCREWDRIVER GAMMA3 380X110MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13200200
Medical Device Problem Codes	Material Deformation (2976); Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
During nail extraction of a long gamma nail, the connection part (inner rod) of the lag screw driver was deformed.The deformation was caused by the surgeon's large movement of the screwdriver after connecting the lag screwdriver to the lag screw.
Event or Problem Description
During nail extraction of a long gamma nail, the connection part (inner rod) of the lag screw driver was deformed.The deformation was caused by the surgeon's large movement of the screwdriver after connecting the lag screwdriver to the lag screw.
Additional Manufacturer Narrative
Correction - please refer - h5 labeled for single use and h8 usage of device the reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: in the received screwdriver, threads are found in bend condition along with dents on the thread.Excess deformation has resulted in one of the pegs of the sleeve to enter in the thread cavity.This suggests that an excess bending force in conjunction with high torsional force has been applied on the device while usage.Due to deformation, the screwdriver is difficult to be separated from the shaft.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 or manufacturing related problems were found during the investigation.Based on the investigation, the root cause was attributed to be a user related issue.The event was caused by application excess torsional and bending forces while usage.Also, the device has been used for more than 15 years which makes it naturally worn out because of the forces it has experienced during its lifecycle and makes it prone to deformation under high loads.If more information is provided, the case will be reassessed.

• Brand Name: LAG SCREWDRIVER GAMMA3 380X110MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 20730625
• Report Number: 0009610622-2024-00918
• Device Sequence Number: 8941389
• Product Code: LXH
• UDI-Device Identifier: 04546540377807
• UDI-Public: 04546540377807
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/07/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 13200200
• Device Lot Number: K558204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2008
• 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: Unknown