MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,6.7X 80MMCANN FULLY THRDED; PLATE, FIXATION, BONE

Catalog Number	AR-8967-80FT
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was requested for evaluation but was not returned, therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Lot number was not provided so device history record review cannot be performed.At this time, it cannot be determined if the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was discarded.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Device was discarded by the facility.
Event or Problem Description
It was reported that during a talo-navicular fusion and calcaneal slide revision procedure, the surgeon was attempting to remove a 6.7 cannulated screw (ar-8967-80ft) with a 3.5mm hex driver.As he was trying to remove the fully threaded screw, the driver shaft broke.A second hex driver was used and again, the shaft broke as he was trying to remove the screw.The surgeon tried again with a third hex driver, this time using power instead of manually and still, the hex driver broke.The screw was finally removed with a synthes broken screw instrument.Additional follow-up information received: original date of surgery is (b)(6) 2015.This was the patients third surgery.The screw was not negatively affecting the patient, rather the patient had an arthritic calcaneal cuboid joint and to resolve this issue, the surgeon wanted to take out the original screws from the first surgery.There was no post op trauma for this patient following the first two surgeries.This was not a non-union operation.

• Brand Name: LO-PRO SCRW,6.7X 80MMCANN FULLY THRDED
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6544173
• Report Number: 1220246-2017-00162
• Device Sequence Number: 616101
• Product Code: HRS
• UDI-Device Identifier: 00888867056640
• UDI-Public: 00888867056640
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: AR-8967-80FT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 05/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR-8967D, HEX CANNULATED DRIVER, LOT UNKNOWN.
• Outcome Attributed to Adverse Event: Other