MAUDE Adverse Event Report: ARTHREX, INC. SELF BUNCHING KL 1.8 FIBERTAK, SHOULDER; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number SELF BUNCHING KL 1.8 FIBERTAK, SHOULDER

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/23/2022

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 (b)(6) 2022, it was reported by a distributor via sems that an ar-3636 1.8 knotless fibertak anchor seemed to be jammed after being inserted halfway and mallet down.The sutures were not able to shuttle so they were cut.At this point, it was noticed that the tip of the inserter had broken off and was stuck in the bone socket.Holes were drilled adjacent to the inserter tip to free it from the bone.Various graspers were used to remove the broken piece.This was discovered during a bankart procedure on (b)(6) 2022.Case was completed without further issues.

• Brand Name: SELF BUNCHING KL 1.8 FIBERTAK, SHOULDER
• 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: 15569621
• MDR Text Key: 305902759
• Report Number: 1220246-2022-05604
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867362871
• UDI-Public: 00888867362871
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K203268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SELF BUNCHING KL 1.8 FIBERTAK, SHOULDER
• Device Catalogue Number: AR-3636
• Device Lot Number: 14961761
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2022
• Date Device Manufactured: 05/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1