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	07/29/2019
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.
Event or Problem Description
It was reported that during a foot & ankle procedure, the screwdriver broke while implanting the cannulated compression screw.Another screwdriver which was immediately available in the o.R.Was used to complete the case successfully with no delay.No adverse consequences reported.
Additional Manufacturer Narrative
The reported event could be confirmed, since pictures of the broken device were provided by hospital.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.Root cause is attributed to improper handling of device by application of excessive torque.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that during a foot & ankle procedure, the screwdriver broke while implanting the cannulated compression screw.Another screwdriver which was immediately available in the o.R.Was used to complete the case successfully with no delay.No adverse consequences reported.

• 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: 8922756
• Report Number: 0008031020-2019-01113
• Device Sequence Number: 2127960
• Product Code: HWC
• UDI-Device Identifier: 07613252708469
• UDI-Public: 07613252708469
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K133451
• 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): 09/18/2019

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: 705212
• Device Lot Number: 07604L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1