MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SET SCREWDRIVER, FLEXIBLE SHAFT, G3 PLUS GAMMA3® 4 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-0234
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/17/2020
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
Primary procedure, left hip.It was reported that at the end of a long gamma nail case, the surgeon tied a suture on the set screw (final screw) due to a concern that the screw might get lost in the patient.When tightening the screw, the suture wrapped around the set screw screwdriver.The entire blue sheath of the screwdriver came off into the nail.The surgeon began attempting to take the nail out, but decided against doing so and completed the case with the blue plastic sheath still in the nail.Surgery was completed with a delay of approximately 30 minutes.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and matches the alleged failure.The received set screwdriver flexible shaft shows heavy scratches of leverage and a dent was observed on the shaft of the screwdriver.The spiral also shows signs of heavy usage with a bulge as well and furthermore found to be partly uncoiled.The ring at the tip is also undamaged and the blue silicon area is in good condition.The appearance shows that during tightening the screw, the suture wrapped around the set screw screwdriver for disassembly of the screwdriver, too high torque forces had been applied onto the set screwdriver.Based on the additional information (blue sheath in the patient) medical opinion was sought from experienced independent medical expert: ¿risk for the patient is not very high¿.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 investigation, the root cause was attributed to a user related issue.The deformation was caused due to high torque forces had been applied onto the set screwdriver.If any further information is provided, the complaint report will be updated.
Event or Problem Description
Primary procedure, left hip.It was reported that at the end of a long gamma nail case, the surgeon tied a suture on the set screw (final screw) due to a concern that the screw might get lost in the patient.When tightening the screw, the suture wrapped around the set screw screwdriver.The entire blue sheath of the screwdriver came off into the nail.The surgeon began attempting to take the nail out, but decided against doing so and completed the case with the blue plastic sheath still in the nail.Surgery was completed with a delay of approximately 30 minutes.

• Brand Name: SET SCREWDRIVER, FLEXIBLE SHAFT, G3 PLUS 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: 9709873
• Report Number: 0009610622-2020-00053
• Device Sequence Number: 3475003
• Product Code: LXH
• UDI-Device Identifier: 07613154978069
• UDI-Public: 07613154978069
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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): 03/20/2020

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: 1320-0234
• Device Catalogue Number: 13200234
• Device Lot Number: K0C9D77
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR