MAUDE Adverse Event Report: ARTHREX, INC. DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET

Device Problem Degraded (1153)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2018

Event Type  Injury  

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.

Event Description

It was reported that the patient underwent a lunate-scaphoid complete tear repair procedure on (b)(6) 2018 when an arthrex device was used to repair a ligament tear in his left wrist.Holes were drilled into his wrist bones and one in the radius.According to the patient, the procedure failed and he now has to undergo another surgery to remove the devices and his wrist bones.Patient further states that a ct scan showed degradation of the holes drilled for the arthrex implant.The second surgery will take place on (b)(6) 2019.The patient believes it would be beneficial to have a representative present during surgery to determine post op on why the initial operation had issue.Additional information obtained 1/18/2019: upon request for additional information, the patient responded that he was just giving arthrex a heads up about his situation but does not want to go through the effort to obtain/provide the information/documents that arthrex has requested.He will ask his current surgeon to provide his opinion upon revision taking place and will let arthrex know the outcome.No part numbers have been provided to date from the original procedure.Additional information obtained 1/22/2019: revision procedure will take place on (b)(6) 2019 at a different facility than the original procedure.Additional information obtained 2/11/2019: the following are the part numbers that were implanted during the original (b)(6) 2018 procedure: ar-8978p dx swivelock sl (lot f201171) qty 1; ar-8978p dx swivelock sl (lot 10185859) qty 3; ar-7276 labraltape (lot s705658) qty 1; ar-7232-02 2-0 fiberwire loop (lot 17901) qty 1.The patient underwent a revision procedure on (b)(6) 2019 during which time the original devices were explanted.During the revision, the surgeon removed the proximal row of bones and inserted an allograft.One anchor is being returned for evaluation and the second anchor was sent to facility lab for testing.Results are unknown at this time.

• Brand Name: DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, 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: 8389922
• MDR Text Key: 137813168
• Report Number: 1220246-2019-00932
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867193925
• UDI-Public: 00888867193925
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET
• Device Catalogue Number: AR-8978P
• Device Lot Number: 10185859
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/19/2018
• 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
• Patient Outcome(s): Other