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

Model Number	703713
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2019
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 device broke off.
Event or Problem Description
The device broke off.
Additional Manufacturer Narrative
Correction: refer to h6 device code.The reported event could be confirmed, since the device was returned with a broken tip on the screwdriver blade.Visual inspection: returned device confirms that the tip of the screwdriver blade is broken.Breakage surface at screwdriver tip displays rough surface pattern consistent with instant breakage when device is placed under excess load.During manufacturing; functionality test and dimensional inspection were performed according to specifications.During the inspection, all devices met the specifications.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by application of excess load on screw driver blade during procedure.If any further information is provided, the complaint report will be updated.

• 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: 9703334
• Report Number: 0008031020-2020-00369
• Device Sequence Number: 2825314
• 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: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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: 703713
• Device Catalogue Number: 703713
• Device Lot Number: J02960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1