MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, MICRO CORKSCREW FT; SCREW, FIXATION, BONE

Model Number SUTURE ANCHOR, MICRO CORKSCREW FT

Device Problems Collapse (1099); Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 08/23/2021

Event Type  Injury  

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  (b)(6) 2021, it was reported by a sales representative via telephone that an ar-1318ft-40 micro corkscrew suture anchor would not seat, the anchor was collapsing.The surgeon tried twice using the ar-1318ft-40. this was discovered during and hand and wrist ucl procedure. the case was completed by repairing the ulnar collateral ligament using 2.0 fiberwire.

• Brand Name: SUTURE ANCHOR, MICRO CORKSCREW FT
• Type of Device: SCREW, FIXATION, BONE
• 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: 12466736
• MDR Text Key: 271237444
• Report Number: 1220246-2021-03618
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00888867008526
• UDI-Public: 00888867008526
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112237
• 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: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SUTURE ANCHOR, MICRO CORKSCREW FT
• Device Catalogue Number: AR-1318FT-40
• Device Lot Number: 12493047
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2021
• Date Device Manufactured: 01/12/2021
• 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