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

Catalog Number	13200200
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
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
As reported: "the thread of the g3 thigh neck screwdriver 1320-0200 bent when screwing in the g3 thigh neck screw 3060-0095s.Thread must not actually bend.No obstacle intraoperatively.Screwing in the screw was easy, but the thread was still bent.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned, and matches the alleged failure.The received lag screwdriver gamma3 was visually inspected we can see that the pegs are slightly deformed, and the threads of the device were completely deformed can see that the crest of threads is flattened up and the crest flank is completely opened.The deformation is caused by the excessive application of force during assembly or improper alignment with the mating part.A functional inspection was carried out with a sample lag screw and found that the device is still functional.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 can be attributed to user-related.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "the thread of the g3 thigh neck screwdriver 1320-0200 bent when screwing in the g3 thigh neck screw 3060-0095s.Thread must not actually bend.No obstacle intraoperatively.Screwing in the screw was easy, but the thread was still bent.".

• 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: 19308582
• Report Number: 0009610622-2024-00190
• Device Sequence Number: 7206239
• Product Code: LXH
• UDI-Device Identifier: 04546540377807
• UDI-Public: 04546540377807
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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: K08E2EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2019
• 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