MAUDE Adverse Event Report: ARTHREX INC. SUTURE ANCHOR PEEK S-TAK KNOTLESS 3X12.7MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number AR-1938PS

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2018

Event Type  Injury  

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.Device history record review revealed nothing relevant to this event.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.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 Description

It was reported that during a case the surgeon was attempting to do a knotless pasta cuff repair and used two knotless suturetak anchors, ar-1938ps, lot 10034125.Once passed, the fiberwire would not tighten.This occurred with both devices.The suture stopped pulling through the body of the anchor.When the suture did not slide the surgeon gave a gentle tug as recommended and both anchors pulled out.The entire case plan had to be aborted and he had to change his approach to complete the case.The surgeon then switched to a corkscrew instead to complete the case.The anchors that were retrieved from the patient were disposed of as they were pretty much destroyed.

• Brand Name: SUTURE ANCHOR PEEK S-TAK KNOTLESS 3X12.7MM
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath, adverse events ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337013
• MDR Report Key: 7248130
• MDR Text Key: 99233003
• Report Number: 1220246-2018-00028
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867024229
• UDI-Public: 00888867024229
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Catalogue Number: AR-1938PS
• Device Lot Number: 10034125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other