MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR,BIO-COMP SUTURE-TAK; SCREW, FIXATION, BONE

Catalog Number	AR-1934BCFT-2
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.This is one of two submissions for the same patient event.The other is 1220246-2016-00575 ((b)(4) (b)(6)).No device malfunction identified.The device was requested but has not been returned to date.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 not returned to arthrex.Additional information has been requested but not made available.Device history record review revealed nothing relevant to this event.This is the first complaint of this type for this part/lot combination.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.
Event or Problem Description
It was reported that two bio composite s-tak suture anchors were being used in a rotator cuff procedure.During the procedure, when the surgeon was tying the graft to the glenoid, the ar-1934bcft-2 lot 600115, suture anchor ((b)(4) (b)(6)) pulled out.The same event happened with the second ar-1934bcft-2 lot 1241015, suture anchor ((b)(4) (b)(6)).The surgeon removed the anchors, and the graft, and cut the remaining sutures from the patient as he decided the rotator cuff was irreparable at this time.The surgery was not completed.

• Brand Name: SUTURE ANCHOR,BIO-COMP SUTURE-TAK
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6184915
• Report Number: 1220246-2016-00576
• Device Sequence Number: 16394836
• Product Code: HWC
• UDI-Device Identifier: 00888867023932
• UDI-Public: 00888867023932
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 12/19/2016

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: 05/01/2017
• Device Catalogue Number: AR-1934BCFT-2
• Device Lot Number: 1241015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2016
• Initial Report FDA Received Date: 12/19/2016
• 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