MAUDE Adverse Event Report: ARTHREX, INC. 5.5MM BC CORKSCREW FT W/ SUTURETAPE; BIO SOFT TISSUE FIXATN FASTNR

Model Number	5.5MM BC CORKSCREW FT W/ SUTURETAPE
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder surgery the anchor was faulty.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update nroe 04-jan-2024: further information revealed that when the anchor was implanted, the screw thread came loose when it was screwed in the bone.This faulty device was completely removed and replaced by an anchor of the same type.No consequences for the patient, apart from a loss of time and therefore a longer anesthesia time.
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.
Additional Manufacturer Narrative
Complaint is confirmed.Visual inspection identified the threads of the tip of the corkscrew of the suture anchor, biocomposite¿ corkscrew® ft, vented 5.5 mm had broken.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation and/or prying/leveraging during use.

• Brand Name: 5.5MM BC CORKSCREW FT W/ SUTURETAPE
• 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: 18496401
• Report Number: 1220246-2024-00299
• Device Sequence Number: 6984952
• Product Code: MAI
• UDI-Device Identifier: 00888867264595
• UDI-Public: 00888867264595
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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 Expiration Date: 03/31/2025
• Device Model Number: 5.5MM BC CORKSCREW FT W/ SUTURETAPE
• Device Catalogue Number: AR-1927BCT-1
• Device Lot Number: 15085839
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2023
• 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