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); Difficult to Insert (1316)

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

Event Date 11/18/2022

Event Type  malfunction  

Event Description

On 11/18/2022, it was reported by a sales representative via sems that (2) ar-3636 1.8 knotless fibertak were having difficulty passing through the drill sleeve, which resulted in both inserter tips to break off.

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.

• 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: 15914508
• MDR Text Key: 307904047
• Report Number: 1220246-2022-05870
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10888867362878
• 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
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• 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: 15002853
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2022
• Date Device Manufactured: 09/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1