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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rotator cuff suture the device broke off when screwing in.There was no harm for patient, operator or third party.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.
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 allegation is confirmed.Visual inspection identified that the implant 4.5mm bio-corkscrew of the 4.5 mm biocomposite-corkscrew® ft suture anchor with one #2 fiberwire® and one tigerwire® had broken off.Functional testing was not performed due to the damage to the device.The method of bone preparation and the quality of the bone encountered were not provided.Per dfu-0087-13 rev 0, section g- precautions: 3.Make sure to use the recommended drill bit or punch to create the bone socket.The most likely cause can be attributed to improper bone preparation or prying/leveraging the screw during insertion.

• Brand Name: BIO-COMPSI CRKSCRW FT 4.5X 14MM
• 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: jared engle ; 8009337001
• MDR Report Key: 19497486
• Report Number: 1220246-2024-05358
• Device Sequence Number: 18124105
• Product Code: MAI
• UDI-Device Identifier: 00888867282391
• UDI-Public: 00888867282391
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/01/2024

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: BIO-COMPSI CRKSCRW FT 4.5X 14MM
• Device Catalogue Number: AR-1927BCF-45-1
• Device Lot Number: 15183790
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2023
• 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