MAUDE Adverse Event Report: ARTHREX, INC. BC, CORKSCREW FT, TRI-PLAY, 4.75MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BC, CORKSCREW FT, TRI-PLAY, 4.75MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
On 08/17/2021, it was reported by a arthrex employee via e-mail that while using an ar-1927bcf-475 corkscrew, the suture anchor broke after the bone hole was created as specified 4.75 mm.The case was completed with a new ar-3680.Additional information provided 8/20/21: the suture anchor was removed from the patient.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation confirms the screw is damaged and fracture.The suture shows no damaged.Functional testing could not be performed due to the damaged received condition of the device.The cause is undetermined; however, most likely causes are improper bone prep, misaligned insertion, prying and/or leveraging the device.

• Brand Name: BC, CORKSCREW FT, TRI-PLAY, 4.75MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12435024
• Report Number: 1220246-2021-03610
• Device Sequence Number: 4739481
• Product Code: MAI
• UDI-Device Identifier: 00888867238541
• UDI-Public: 00888867238541
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: BC, CORKSCREW FT, TRI-PLAY, 4.75MM
• Device Catalogue Number: AR-1927BCF-475
• Device Lot Number: 12208139
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1