MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWVLK SP, 4.75X24.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP SWVLK SP, 4.75X24.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 24 june 2024, it was reported by a sales representative via email that 2 x ar-2324bcm-1 bio-comp swvlk sp, 4.75x24.5mm were reported to have failed during use.This occurred on (b)(6) 2024 in (b)(6) hospital during a left arthroscopic biceps tenodesis and rotator cuff repair with sub acromial decompression.It was reported the swivelock anchor was loaded with x four tails of suturetape ar-7501.The anchor was inserted into the lateral aspect of the humeral head using a mallet.With each tap of the mallet on the swivelock only small progress was made into the cortical bone, more pressure was applied with each tap of the mallet with the same progress.By this stage it was decided to remove the swivelock from the bone as something was not right with the usual insertion of a self-punching swivelock.The surgeon tried to remove the swivelock, however the metal eyelet had engaged into the bone deep enough so that it could not be removed and the swivelock anchor had broken in half.The surgeon attempted to remove the metal eyelet but it was buried too deep into the humeral head.Another swivelock anchor was used, but with the same result, so a punch and tap were used which resulted in successful lateral row.The end results were two self-punching swivelock not successfully implanted, with one metal eyelet left in the humeral head and one completely removed.The case was completed successfully using 2 x ar-2324bcc-1 with the relevant awl and tap.There was case involvement.
Additional Manufacturer Narrative
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces upon insertion.

• Brand Name: BIO-COMP SWVLK SP, 4.75X24.5MM
• 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: jared engle ; 8009337001
• MDR Report Key: 19763986
• Report Number: 1220246-2024-06798
• Device Sequence Number: 18278105
• Product Code: MAI
• UDI-Device Identifier: 00888867098039
• UDI-Public: 00888867098039
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 09/23/2024

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 SWVLK SP, 4.75X24.5MM
• Device Catalogue Number: AR-2324BCM-1
• Device Lot Number: 15138246
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2023
• 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