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 09/26/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, it was reported by a sales representative via email that an ar-3636 knotless fibertak, upon insertion, resistance was met and surgeon proceeded to mallet in hopes of getting past that initial resistance.When the anchor driver was pulled out, it was noticed the tip of the driver had broken off and was imbedded in the bone.Surgeon attempted multiple times to remove the broken piece until eventually, both the implant and broken metal piece came out.Case was completed by drilling a new hole and using another fibertak without further issues.This was discovered during an anterior labral repair procedure.

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.

Manufacturer Narrative

Visual inspection found that the end of the device was broken off.Device was returned without suture assembly.Complaint was confirmed.

• 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: 15614830
• MDR Text Key: 301827724
• Report Number: 1220246-2022-05610
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867362871
• UDI-Public: 00888867362871
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SELF BUNCHING KL 1.8 FIBERTAK, SHOULDER
• Device Catalogue Number: AR-3636
• Device Lot Number: 14960284
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other