MAUDE Adverse Event Report: STRYKER GMBH G4 LAG SCREW DRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1420-0260
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "gamma4 lag screwdriver stripped and broke.5 minutes surgical delay.The procedure was completed with a new tray.No debris reported.".
Additional Manufacturer Narrative
The reported event could be confirmed based on the inspection performed.The device inspection revealed the following: the identification of the returned lag screw was confirmed based on the catalog # and the lot # marked.The instrument is heavily worn out, multiple scratches are visible on the compression wheel, which cannot be turned.The screwdriver shaft is slightly deformed and is not straight, damages can also be observed on the threads.This gives explanation to why the compression wheel is blocked.The wear observed on the compression wheel is most probably due to careless handling such as falling on the floor but also the possible off-label use of instruments (pliers) in order to tighten or untighten it.Based on investigation, the root cause was attributed to an user related issue.The failure was caused by careless handling of the instrument and possible off-label use of an instrument in order to turn the compression wheel.As a reminder, the instructions for use clearly state: "only use the instrument for its intended purpose as described in the operative technique for the product system.Off-label use of an instrument can harm the patient and/or impair the function and integrity of the instrument." 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.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "gamma4 lag screwdriver stripped and broke.5 minutes surgical delay.The procedure was completed with a new tray.No debris reported.".

• Brand Name: G4 LAG SCREW DRIVER
• 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: 16685214
• Report Number: 0009610622-2023-00102
• Device Sequence Number: 7967496
• Product Code: LXH
• UDI-Device Identifier: 07613327510089
• UDI-Public: 07613327510089
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2023

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: 1420-0260
• Device Catalogue Number: 14200260
• Device Lot Number: KWE221008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2022
• 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 Sex: Female