MAUDE Adverse Event Report: ARTHREX, INC. LABRALTAPE, WHITE 1.5MM 36"; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	LABRALTAPE, WHITE 1.5MM 36"
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/10/2018
Type of Reportable Event	Serious Injury
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.
Event or Problem 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).Ar-8978p, dx swivelock sl, (lot 10185859).Ar-7276, labraltape, (lot s705658).Ar-7232-02 2-0, fiberwire loop, (lot 17901).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: LABRALTAPE, WHITE 1.5MM 36"
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8389937
• Report Number: 1220246-2019-00933
• Device Sequence Number: 16465845
• Product Code: GAT
• UDI-Device Identifier: 00888867041936
• UDI-Public: 00888867041936
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: LABRALTAPE, WHITE 1.5MM 36"
• Device Catalogue Number: AR-7276
• Device Lot Number: S705658
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other