MAUDE Adverse Event Report: ARTHREX, INC. NANO CORKSCREW FT, TI, W 3-0 FW; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number NANO CORKSCREW FT, TI, W 3-0 FW

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Date 11/03/2021

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

On 11/4/2021, it was reported by a sales representative via email that an ar-1317ft nano corkscrew was inserted appropriately and anchor was countersunk into bone; however, after surgeon passed one end of the fiberwire through the tendon, the sutures snapped off the anchor when surgeon pulled on them to tighten.This was discovered during a ecu repair on (b)(6) 2021.Anchor was left inside the patient and a new one was implanted, surgeon was unable to retrieve any broken pieces.Additional information received 11/4/2021: per sales representative, since surgeon could not remove ar-1317ft nano corkscrew anchor after the sutures snapped, a ar-1322bcnf suturetak anchor was implanted on top of the failed anchor.All broken fragments and sutures were successfully removed from the patient.

• Brand Name: NANO CORKSCREW FT, TI, W 3-0 FW
• 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: 12854528
• MDR Text Key: 282277700
• Report Number: 1220246-2021-03998
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867276703
• UDI-Public: 00888867276703
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NANO CORKSCREW FT, TI, W 3-0 FW
• Device Catalogue Number: AR-1317FT
• Device Lot Number: 12936193
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2021
• Date Device Manufactured: 03/18/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1