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

Catalog Number	13200200
Medical Device Problem Codes	Material Deformation (2976); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the connection between the lag screw driver and the lag screw was not properly made, leading difficulty in removing the lag screw.The doctor told that he felt the thread part at the tip of the lag screw driver was stripped".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device disposition unknown.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned, and it matches the alleged failure.The returned lag screwdriver was visually inspected, where we can see that the corner edges of the pegged are bent which can be due to improper alignment and application of excessive torsional force which can also be confirmed with rotational marking at the end of the threaded rod.The threads are flattened completely which is caused by either overtightening or hitting the distal region as we also have a flattened surface at the cylindrical end of the rod.A functional inspection was conducted by the sample lag screw where we can see the locking cannot be done properly because of the deformed starting threads of the lag screw.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 an user related issue as we can clearly see signs of excessive force application.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the connection between the lag screw driver and the lag screw was not properly made, leading difficulty in removing the lag screw.The doctor told that he felt the thread part at the tip of the lag screw driver was stripped.".

• 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: 17667619
• Report Number: 0009610622-2023-00299
• Device Sequence Number: 7123753
• 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): 10/19/2023

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 Catalogue Number: 13200200
• Device Lot Number: K144D13
• 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: 08/08/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• 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 Age: 32 YR
• Patient Sex: Male