MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BLADE T10 AO FITTING; PLATE, FIXATION, BONE

Catalog Number	703713
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2019
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
It was reported that when the screw was tightened with driver blade, tip of the driver blade was broken.All broken parts were removed from the patient's body.After that, screw was inserted with other driver and the operation was finished successfully.No adverse consequences or surgical delay were 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 an over-torque.As an excessive force was applied to the part, the fracture was initiated.As more force was applied, it finally breaks.The microscope investigation showed a fibrous surface with some traces of rust.Torsion lines were also visible on the surface breakage, showing that the breakage was caused by torsional overload.The instruction for use clearly reminds to "always treat the instrument carefully to avoid surface damage or alterations to the instrument geometry." moreover, if a power insertion was used at a high speed such an event can occur.As stated in the operative technique guide "using the screwdriver blade and the handle, insert the screws until the head is properly seated in the hole.If power insertion is used, it must be used at low speed." therefore, this case is classified as a user related issue.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.
Event or Problem Description
It was reported that when the screw was tightened with driver blade, tip of the driver blade was broken.All broken parts were removed from the patient's body.After that, screw was inserted with other driver and the operation was finished successfully.No adverse consequences or surgical delay were reported.

• Brand Name: SCREWDRIVER BLADE T10 AO FITTING
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8474786
• Report Number: 0008031020-2019-00342
• Device Sequence Number: 2689714
• Product Code: HRS
• UDI-Device Identifier: 04546540687647
• UDI-Public: 04546540687647
• Combination Product (Y/N): N
• PMA/510(K) Number: K170727
• 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): 06/03/2019

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: 703713
• Device Lot Number: J03622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR