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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2023

Event Type  malfunction  

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.

Event Description

It was reported that during a surgery the swivelock anchors could not be fixed one after the other.Anchors could be screwed in directly after drilling but came out of the bone again immediately.There was no harm for patient, operator or third party.The surgery was finished successfully with a different device, ar-2323-1.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: BIO-COMP SWVLK 3.5X 15.8MM
• Type of Device: 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: 18374497
• MDR Text Key: 331199938
• Report Number: 1220246-2023-09557
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867283626
• UDI-Public: 00888867283626
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K101823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/21/2023

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
• Device Operator: Health Professional
• Device Model Number: BIO-COMP SWVLK 3.5X 15.8MM
• Device Catalogue Number: AR-2325BCC-1
• Device Lot Number: 15074892
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1