MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a shoulder arthroscopy it was not possible to screw the devices in and the thread of both devices is defect.No part of the device broke off.According to the surgeon no harm or adverse event 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.Update 11-may-2021: it was reported that no broken parts remained inside the patient.Although the anchor broke no parts of the device came off and the device could be removed in one part.
Additional Manufacturer Narrative
Complaint confirmed.-two unpackaged ar-2323bcc-1 swivelocks (no batch indicator present) were received for investigation.Visual inspection identified that the biocomposite anchor at the distal end of one swivelock had broken at the second thread.Inspection of the second returned swivelock revealed that the biocomposite anchor associated with the device was damaged/warped as well.Using digital caliper id: 011, it was determined that both anchors sustained damage at approximately 3.19mm from the distal end of the anchor.The observed condition of both anchors is most likely the result of prying/leveraging the swivelock drivers during insertion.

• Brand Name: BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11872333
• Report Number: 1220246-2021-03151
• Device Sequence Number: 16487534
• Product Code: MAI
• UDI-Device Identifier: 00888867097919
• UDI-Public: 00888867097919
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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 C, CLD 5.5X19.1MM
• Device Catalogue Number: AR-2323BCC-1
• Device Lot Number: 12798092
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 07/07/2021
• Patient Sequence Number: 1