MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BLADE, T7; PLATE, FIXATION, BONE

Model Number	62-27015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2020
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
As reported: "the screw could not be inserted.The tip may be deformed." device image showed tip fracture.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.Visual inspection: the visual inspection confirmed that the tip of the screw driver is deformed, a sign that the part was extensively used.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 be user related.The failure was caused by the normal wear of the device.If any further information is provided, the investigation report will be updated.
Event or Problem Description
As reported: "the screw could not be inserted.The tip may be deformed." device image showed tip fracture.

• Brand Name: SCREWDRIVER BLADE, T7
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9829866
• Report Number: 0008031020-2020-00692
• Device Sequence Number: 10944430
• Product Code: HRS
• UDI-Device Identifier: 04546540594150
• UDI-Public: 04546540594150
• Combination Product (Y/N): N
• PMA/510(K) Number: K141430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020

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: 62-27015
• Device Catalogue Number: 62-27015
• Device Lot Number: Z12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1