MAUDE Adverse Event Report: ARTHREX, INC. DX SWIVELOCK, 3.5 X 13.5 MM; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number DX SWIVELOCK, 3.5 X 13.5 MM

Device Problems Unstable (1667); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 11/17/2021

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 implant failed to anchorage and remained unstable.The surgeon reported that there was no harm for patient, operator or third party.The surgery was finished successfully.No further information received.

Manufacturer Narrative

Complaint not confirmed, the ar-8979p-1 was returned without the anchor.No abnormalities were observed on the returned device.

• Brand Name: DX SWIVELOCK, 3.5 X 13.5 MM
• Type of Device: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 12983508
• MDR Text Key: 283765053
• Report Number: 1220246-2021-04083
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867287709
• UDI-Public: 00888867287709
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K150648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DX SWIVELOCK, 3.5 X 13.5 MM
• Device Catalogue Number: AR-8979P-1
• Device Lot Number: 13409002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1