MAUDE Adverse Event Report: STRYKER GMBH CANNULATED T7 DRIVER SHAFT, QC FITTING AUTOFIX 2.0/2.5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	901-1017
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
As reported: "tip of screwdriver broke while inserting 2.0 screw.Finished case with solid screwdriver.".
Additional Manufacturer Narrative
The reported event that cannulated t7 driver shaft, qc fitting autofix 2.0/2.5 was alleged of "instrument - breakage during implantation" could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "tip of screwdriver broke while inserting 2.0 screw.Finished case with solid screwdriver.".

• Brand Name: CANNULATED T7 DRIVER SHAFT, QC FITTING AUTOFIX 2.0/2.5
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9923563
• Report Number: 0008031020-2020-01036
• Device Sequence Number: 14235820
• Product Code: HXX
• UDI-Device Identifier: 03700586902978
• UDI-Public: 03700586902978
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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): 07/14/2020

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: 901-1017
• Device Catalogue Number: 9011017
• Device Lot Number: P1619
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 07/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1