MAUDE Adverse Event Report: ARTHREX, INC. LABRAL TAPE, WHITE 1.5MM 36"; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	AR-7276
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/01/2017
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 contribution of the device to the reported event could not be determined as the device was not returned for evaluation 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.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.Per customer device not being returned.
Event or Problem Description
It was reported that the patient underwent a 2b slap repair procedure on (b)(6) 2015 where multiple 2.9mm pushlocks, ar-2923bc, and labral tape, ar-7276 lot: unk ((b)(4)) were implanted.On (b)(6) 2017 the patient underwent a revision surgery due to joint noise and pain in the shoulder.During the revision surgery, it was noticed that the labraltape was loose on one anchor.The surgeon said none of the labraltape were covered in synovial tissue like he would normally see with fiberwire suture.The previously implanted labraltape, ar-7276 lot: unk, was removed and four 3.5 bio-composite swivelock (ar-2325bcc) with suturetape (ar-7500) and three 2.9 short bio-comp pushlock (ar-2923bc) with suturetape (ar-7500) were implanted.

• Brand Name: LABRAL TAPE, WHITE 1.5MM 36"
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6630323
• Report Number: 1220246-2017-00206
• Device Sequence Number: 19158977
• Product Code: GAT
• UDI-Device Identifier: 00888867041936
• UDI-Public: 00888867041936
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 06/09/2017

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-7276
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2017
• Initial Report FDA Received Date: 06/09/2017
• 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