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 Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
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: "during a nail removal, the screwdriver tip deformed.The patient had implants 20 years ago and the bone appeared to be hard.".
Event or Problem Description
As reported: "during a nail removal, the screwdriver tip deformed.The patient had implants 20 years ago and the bone appeared to be hard.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned, and matches the alleged failure.Device inspection revealed the following: the received lag screwdriver was visually inspected in which we can see that the threaded rod is bent in one direction and the cylindrical rod shape is also completely deformed which indicates the application of excessive force from one direction leading to deformation.The pegs are completely broken off and the broken section was not returned the breakage is brittle in a manner as the breakage area is shiny in nature the breakage happened due to the application of excessive torsional and bending load.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 user-related.If any additional information is provided, the investigation 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: 17305414
• Report Number: 0009610622-2023-00230
• Device Sequence Number: 17801789
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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: K0BFC13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2022
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 47 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian