MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREWDRIVER FIXOS T30, LARGE AO FITTING; SCREW, FIXATION, BONE

Catalog Number	705212
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed, any additional information will be reported in a supplemental report.
Event or Problem Description
Fixos 7.0 screwdriver tip broke while inserting screw by hand.Increased tourniquet time due to switching drivers and picking out broken pieces.

• Brand Name: CANNULATED SCREWDRIVER FIXOS T30, LARGE AO FITTING
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7073007
• Report Number: 0008031020-2017-00677
• Device Sequence Number: 1260893
• Product Code: HWC
• UDI-Device Identifier: 07613252708469
• UDI-Public: 07613252708469
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K133451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2017

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: 705212
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other