MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SET SCREWDRIVER, FLEXIBLE SHAFT GAMMA3® 4 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-0233
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "i felt resistance when inserting the set screw, but inserted the screwdriver as it was.I felt that i couldn't proceed while turning the driver.Once the driver was removed, the flexible part was damaged." the procedure was completed using a set screwdriver prepared in another case.After the surgery, the doctor said, "the end caps are floating a little more than usual.".
Event or Problem Description
As reported: "i felt resistance when inserting the set screw, but inserted the screwdriver as it was.I felt that i couldn't proceed while turning the driver.Once the driver was removed, the flexible part was damaged." the procedure was completed using a set screwdriver prepared in another case.After the surgery, the doctor said, "the end caps are floating a little more than usual.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the returned device matches the reported failure mode.The device inspection revealed the following: the received set screwdriver shows significant traces of intense and frequent use as evident by scratches and slightly worn out drive.The flexible spring of the set screwdrivers was severely deformed and uncoiled irreversibly.This is a clear indication of a forcible use under high torsion.Evidence of intense usage can also be found on the cylindrical portion proximal to the drive.The handle of the screwdriver was however found unscathed.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 manufacturing or design related problems were found during the investigation.A review of the labelling did not indicate any abnormalities.Based on the above investigation, the root cause was attributed to user related issue.The deformation of the spiral occurred due to application of a high torsional load.The deformation pattern reveals it was turned both in clockwise and counterclockwise direction under high torque to successfully insert the set screw, as the surgeon felt a slight resistance while inserting.The op-tech mentions about facing a resistance while inserting: ¿push the set screwdriver down until you are sure that the set screw engages the corresponding thread in the nail.During pushing down the assembly, you may feel a slight resistance.Turn the screwdriver handle clockwise under continuous pressure.You may notice a resistance when turning the set screw.This is because the set screw thread is equipped with the ¿nylstop¿ system to prevent spontaneous loosening.This is not the final position for the set screw.Keep turning the set screw until you feel contact in one of the grooves of the lag screw.¿ if any further information is provided, the complaint report will be updated.

• Brand Name: SET SCREWDRIVER, FLEXIBLE SHAFT GAMMA3® 4 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9845750
• Report Number: 0009610622-2020-00115
• Device Sequence Number: 11495323
• Product Code: LXH
• UDI-Device Identifier: 04546540592545
• UDI-Public: 04546540592545
• Combination Product (Y/N): N
• 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): 05/07/2020

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: 1320-0233
• Device Catalogue Number: 13200233
• Device Lot Number: K134287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1