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

Catalog Number	13200200
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
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: "femoral neck screw can no longer be properly tightened by the instrument.Thread does not engage.Replacement was available.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and matches the alleged failure.The received device was visually inspected and where we can see scratch marks on the surface of the device which indicates towards usage of the device over a year.Looking at the distal end we can see a deformation on the pegs, we also see that the distal threads are deformed crest surface is flattened and nicked at various sections.A functional inspection was conducted by a sample lag screw in which we can see that the lag screw was not completely assembled it is stuck in between because of deformation in the threads.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 multifactorial user related and normal wear as the device has been in use for 8+ years.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "femoral neck screw can no longer be properly tightened by the instrument.Thread does not engage.Replacement was available.".

• 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: 18717588
• Report Number: 0009610622-2024-00072
• Device Sequence Number: 15103645
• 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): 05/01/2024

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: K0301F3
• 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: 01/22/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2015
• 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