MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BLADE VARIAX AO, T7, SELF RETAINING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	703665
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2019
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
When the locking screw was inserted and final tightened, the tip of the screwdriver was broken.The broken tip of the driver remains in the screw head.Attempted to remove it, but could not extract it.Since the broken part protruded from the screw head, it was machined so as to shave off using an air drill, and it was completed the procedure.
Additional Manufacturer Narrative
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: visual inspection: the tip of the returned device was found to be broken.The breakage surface of the blade is twisted showing torsional deformation, and the broken edges are sharp without any signs of rust.Such a twisted pattern is consistent with over-torqueing of the device.The root cause of the failure was repeated powerful dynamically overload during use.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.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by over torque.As per ifu, "ensure that you are familiar with the recommended uses, compatibility and correct handling of the instrument.Always treat the instrument carefully to avoid surface damage or alterations to the instrument geometry.Before every operation, ensure that all devices to be used during the operation function correctly with each other." regular functional check and visual inspection is recommended.If any further information is provided, the complaint report will be updated.
Event or Problem Description
When the locking screw was inserted and final tightened, the tip of the screwdriver was broken.The broken tip of the driver remains in the screw head.Attempted to remove it, but could not extract it.Since the broken part protruded from the screw head, it was machined so as to shave off using an air drill, and it was completed the procedure.

• Brand Name: SCREWDRIVER BLADE VARIAX AO, T7, SELF RETAINING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8449768
• Report Number: 0008031020-2019-00310
• Device Sequence Number: 1288799
• Product Code: LXH
• UDI-Device Identifier: 04546540652386
• UDI-Public: 04546540652386
• 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): 05/22/2019

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: 703665
• Device Lot Number: 00002F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other