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

Model Number	1320-0200
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
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: "spikes on screwdriver broken off at front, thread loose on wire." there was a 60 minute surgical delay.All debris was removed from the patient.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned, and matches the alleged failure.The device inspection revealed the following: the received lag screwdriver was visually inspected in which out of the four pegs, one peg was completely broken, and the broken end was not returned, the second peg was deformed in a manner that it is bent 90 degrees.The visual scratches over the surface indicate usage over time and the threads are completely flattened.The deformation and breakage of the peg is brittle in nature confirmed by the shiny surface of the broken region which is resultant of the application of a high torsional load.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.Due to the fact that this device was manufactured in 2007, and has more than 10 years of compliant performance, a material analysis was not deemed necessary, since if there were any material related issues, it would have been evident in the beginning of life of the device.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 a user related issue as plate as there were signs of application of high torsional load.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "spikes on screwdriver broken off at front, thread loose on wire." there was a 60 minute surgical delay.All debris was removed from the patient.
Event or Problem Description
As reported: "spikes on screwdriver broken off at front, thread loose on wire." there was a 60 minute surgical delay.All debris was removed from the patient.

• 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: 16426606
• Report Number: 0009610622-2023-00058
• Device Sequence Number: 14114742
• 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,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 Model Number: 1320-0200
• Device Catalogue Number: 13200200
• Device Lot Number: K533495
• 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: 01/31/2023
• Supplement Date Received by Manufacturer: 04/12/2023; 09/26/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 05/09/2023; 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2007
• 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: 40 YR
• Patient Sex: Unknown