MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, BIO-CORKSCREW FT; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number SUTURE ANCHOR, BIO-CORKSCREW FT

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2021

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that during a rotator cuff refixation three devices failed.The sutures could not be released.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update (b)(6) 2021 further information were provided that three implants were partially implanted and then the sutures became detached.Therefore all implants had to be retrieved and with the 4th implant the case could be completed successfully.

• Brand Name: SUTURE ANCHOR, BIO-CORKSCREW FT
• Type of Device: FASTENER, FIXATION, NON-DEGRADABLE, 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 ; 8009337001
• MDR Report Key: 11931130
• MDR Text Key: 257735186
• Report Number: 1220246-2021-03200
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867096783
• UDI-Public: 00888867096783
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SUTURE ANCHOR, BIO-CORKSCREW FT
• Device Catalogue Number: AR-1927BCF-1
• Device Lot Number: 11428309
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2021
• Date Device Manufactured: 08/03/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1