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

Catalog Number	45-27015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2019
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
Surgeon reported that a screwdriver blade broke during surgery.Procedure was completed successfully with no adverse consequences or surgical delay reported.
Event or Problem Description
Surgeon reported that a screwdriver blade broke during surgery.Procedure was completed successfully with no adverse consequences or surgical delay reported.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by too high applied forces during use.The device inspection revealed the following: the tip of the returned screwdriver blade is indeed completely broken / snapped off.The fracture surface shows clearly some cracks.Note that this device just manufactured in march 2019, which surely gives us an indication that far too much torsional force has resulted in the tip breakage.Note: the lifetime of the device is not specified, but as stated in the cleaning and sterilization guide : ¿ [¿] stryker trauma & extremities typically does not specify the maximum number of uses appropriate for re-usable medical devices.The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.[¿]¿.Based on the above-mentioned observations the case could be classified as user-related.The ifu guide advises that during engaging the screw, axial pressure of the screwdriver into the screw head must be adequately applied to ensure that the blade is fully inserted into the screw head.This results in proper axial alignment and full contact between driver and screw, minimizing the risk of damage and leading to optimal friction fit performance.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.If any further information is provided, the investigation report will be updated.

• Brand Name: SCREWDRIVER BLADE, T7, AO
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9079690
• Report Number: 0008031020-2019-01284
• Device Sequence Number: 11417143
• Product Code: LXH
• UDI-Device Identifier: 04546540540423
• UDI-Public: 04546540540423
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• 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): 11/15/2019

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: 45-27015
• Device Lot Number: AK04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1