MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWIVELOCK SP, 5.5X24.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP SWIVELOCK SP, 5.5X24.5MM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery the anchor couldn`t be fixed, it was rotating.According to the surgeon no harm for patient, operator or third party occurred.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
Additional information: d9, g3, h3, h6 complaint is confirmed.Visual inspection identified that the bio-screw at the distal end of the tip suture anchor, bio-composite swivelock® sp, 5.5 x 24.5 mm, self-punching , vented had broken.The eyelet and driver returned no issues were found.Functional testing noted that the driver works smoothly as required.The method used to prepare the bone, as well as the bone quality encountered, was not provided.Per dfu-0087-eo revision 2.G.Precautions.3.Make sure to use the recommended drill bit or punch to create a bone socket.8.Self-punching pushlock and swivelock suture anchors only: ensure that the angle of anchor insertion is perpendicular to the bone.The most likely cause for the reported failure can be attributed to improper bone preparation, misalignment insertion of the device during insertion; prying/leveraging the device during insertion.

• Brand Name: BIO-COMP SWIVELOCK SP, 5.5X24.5MM
• 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: 17976722
• Report Number: 1220246-2023-08280
• Device Sequence Number: 3568658
• Product Code: MAI
• UDI-Device Identifier: 00888867097926
• UDI-Public: 00888867097926
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K151342
• 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): 11/12/2024

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 Model Number: BIO-COMP SWIVELOCK SP, 5.5X24.5MM
• Device Catalogue Number: AR-2323BCM-1
• Device Lot Number: 15097478
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2023
• 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