MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SPREADING SCREWDRIVER, BALL TIP GAMMA3® 8 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13200066
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2019
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
The driver was broken during the gamma 3 implant procedure.A back-up device was used to complete the procedure.No surgical delay or adverse consequences were reported.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.Device inspection revealed the following: the visual inspection of the device was done.The spreading screwdriver showed significant traces of an intense and frequent uses.Screwdriver received was found to be completely broken off at distal end.The broken off pieces returned, and it can be concluded that the product has rotated in counter clockwise direction by applying load, the breakage surface showed the typical structure of a forced, ductile fracture due to overload.It has been in use for a long time (manufactured in 2009), therefore it is assumed that the device had fulfilled its tasks in former surgeries as intended without problems reported.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by due to application of excess torsional force rotated in counter clockwise direction.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 labeling did not indicate any abnormalities.The instructions for use instructs user that: "only use an instrument for its intended purpose.Improper use of instruments might lead to loss in function or usage.[¿] always treat the instrument carefully to avoid surface damage or alterations to the instrument geometry.The design of the instrument must not be modified in any way." if any further information is provided, the investigation report will be updated.
Event or Problem Description
The driver was broken during the gamma 3 implant procedure.A back-up device was used to complete the procedure.No surgical delay or adverse consequences were reported.

• Brand Name: SPREADING SCREWDRIVER, BALL TIP GAMMA3® 8 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8843777
• Report Number: 0009610622-2019-00596
• Device Sequence Number: 259811
• Product Code: LXH
• UDI-Device Identifier: 04546540487667
• UDI-Public: 04546540487667
• 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): 09/30/2019

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 Catalogue Number: 13200066
• Device Lot Number: K275966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1