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

Model Number	1320-0200
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	09/07/2022
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
It was reported that one of the teeth at the end of the lag screwdriver came off during the procedure.
Additional Manufacturer Narrative
Correction - d4 (lot#), h6 (clinical signs code, health impact code, component code).The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received lag screwdriver shows traces of intense use identified by the appearance of scratches & dents on the surface.One of the four pegs was found to be broken and was not returned for evaluation.All the remaining pegs showed signs of deformation.Most likely the breakage occurred due to torsional overload.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation and available information, the root cause was attributed to user related issue.The breakage & deformation in pegs indicates towards torsional overloading.Moreover, the device was manufactured in 2011, so it can be said that it has performed its function in the previous surgeries as intended without any reported failure.Since it has been long in use, thus a normal weakened structural integrity due to repeated reprocessing cycles is considered possible.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that one of the teeth at the end of the lag screwdriver came off during the procedure.The surgeon attempted to retrieve the fragment but it was unsuccessful.The procedure was completed successfully, but a fragment from the ¿screwdriver¿ device had to be left in the patient.

• Brand Name: LAG SCREWDRIVER GAMMA3® 380X110MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• 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: 15526176
• Report Number: 0009610622-2022-00449
• Device Sequence Number: 2674692
• Product Code: LXH
• UDI-Device Identifier: 04546540377807
• UDI-Public: 04546540377807
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2022

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: K949634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 10/02/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2011
• 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