MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPSI CRKSCRW FT 4.5X 14MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number BIO-COMPSI CRKSCRW FT 4.5X 14MM

Device Problem Break (1069)

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

Event Date 03/21/2024

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 3/29/2024, it was reported by an arthrex subsidiary employee via email that an ar-1927bcf-45 biocomposite-corkscrew ft anchor broke during insertion.Another r-1927bcf-45 biocomposite-corkscrew ft was used to complete the case.This was discovered during an elbow joint ligament repair procedure on (b)(6) 2024.Everything was removed from inside the patient.Additional information received on 4/11/2024: the case was delayed fifteen minutes; however, additional anesthesia was unnecessary.The patient suffered no negative effects on or after the procedure.

• Brand Name: BIO-COMPSI CRKSCRW FT 4.5X 14MM
• Type of Device: BIO SOFT TISSUE FIXATN FASTNR
• 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: jared engle ; 8009337001
• MDR Report Key: 19166740
• MDR Text Key: 340962157
• Report Number: 1220246-2024-02273
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867023376
• UDI-Public: 00888867023376
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K082810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BIO-COMPSI CRKSCRW FT 4.5X 14MM
• Device Catalogue Number: AR-1927BCF-45
• Device Lot Number: 15106547
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/20/2023
• 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