MAUDE Adverse Event Report: ARTHREX INC. SUTURE ANCHOR,FASTAK,SM BONE; SCREW, FIXATION, BONE

Catalog Number	AR-1322-752SF
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2017
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 received and an evaluation was conducted.The complaint was confirmed.Device history record review revealed nothing relevant to this event.The evaluation revealed that suture is broken off near the midsection.Further evaluation revealed that the anchor's hex portion was severely damaged.There were sharp edges on the proximal end of the anchor.This type of event is typically caused by nicking the suture with another instrument and/or fraying from sharp edge of the bone tunnel.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a wrist ligament reattachment procedure, the surgeon screwed in the fasttak, unslid the door, pulled out the handle and began to attach the tendon when the fiberwire snapped-off from the base of the anchor leaving two tails with needles on each.The anchor was removed and the surgeon drilled tunnels and passed suture to tie the tendon down instead.The case was completed with no adverse effect to the patient.Follow-up investigation: all components were retrieved from the patient.The inserter with metal anchor and suture are being sent back to arthrex for evaluation.

• Brand Name: SUTURE ANCHOR,FASTAK,SM BONE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7048069
• Report Number: 1220246-2017-00441
• Device Sequence Number: 864453
• Product Code: HWC
• UDI-Device Identifier: 00888867010130
• UDI-Public: 00888867010130
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 11/21/2017

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 Expiration Date: 03/01/2018
• Device Catalogue Number: AR-1322-752SF
• Device Lot Number: 769864
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 11/21/2017
• 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