MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWVLK 3.5X 15.8MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP SWVLK 3.5X 15.8MM
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On the 12th march 2023 it was reported via email that an (suture anchor, biocomposite¿ swivelock®, 3.5 x 15.8 mm, vented) - (batch#14992663) had an issue where the surgeon was performing a lateral ligament stabilisation and when he was trying to insert the limbs of the fibertape into the eyelet of the 3.5 swivelock (ar-2325bcc), they would not fit.He tried several times to pull it through to no avail.They decided to open a second anchor and the tape passed through the eyelet without any issues.There was a case and patient involved.Another anchor was opened to complete the case.
Additional Manufacturer Narrative
The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error due to trying to insert the limbs of the fibertape without a suture threader.

• Brand Name: BIO-COMP SWVLK 3.5X 15.8MM
• 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: 19528296
• Report Number: 1220246-2024-05677
• Device Sequence Number: 12637876
• Product Code: MAI
• UDI-Device Identifier: 00888867283626
• UDI-Public: 00888867283626
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

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 3.5X 15.8MM
• Device Catalogue Number: AR-2325BCC-1
• Device Lot Number: 14992663
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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