MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, BIO-CORKSCREW FT; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTURE ANCHOR, BIO-CORKSCREW FT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/06/2023
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 11/06/2023, it was reported by a sales representative via (b)(4) that an ar-1927bcf suture anchor backed out.This occurred during a case where the device was inserted into the patient's bone and came out.The case was completed using another device.
Additional Manufacturer Narrative
Complaint is confirmed.Upon visual evaluation, it was noted that the threads of the bio-screw were damaged.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed user error due to improper bone prep and/or misaligned insertion.

• Brand Name: SUTURE ANCHOR, BIO-CORKSCREW FT
• Common Device Name: 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: emily shafer ; 8009337001
• MDR Report Key: 18229313
• Report Number: 1220246-2023-08991
• Device Sequence Number: 15005620
• Product Code: MAI
• UDI-Device Identifier: 00888867023352
• UDI-Public: 00888867023352
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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
• Operator of Device: Health Professional
• Device Model Number: SUTURE ANCHOR, BIO-CORKSCREW FT
• Device Catalogue Number: AR-1927BCF
• Device Lot Number: 15096466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown