MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH MINI BC S-TAK 2.4X 8.5MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCH MINI BC S-TAK 2.4X 8.5MM
Health Effect - Clinical Code	Reaction (2414)
Date of Event	03/08/2018
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 a patient who underwent a scapho-lunate ligament repair surgery in the wrist on (b)(6) 2018 developed in (b)(6) 2019 pain in the left wrist.A biopsy was performed and a foreign body reaction, probably caused by the suture which is attached to the anchor, was identified.It was further reported that lytic areas (holes) have been formed at the site of the inserted anchor which may lead to an arthritis in the future.Update 07-oct-2020: further information was provided that the pain was found on (b)(6) 2019 and that the initial surgery was also performed by the same surgeon.A follow up surgery was performed on (b)(6) 2019.The surgeon removed the suture material and the remaining fragments of the anchor.An biopsy was done and the samples were sent to histology and showed that the patient had a tissue reaction to some foreign material.The reaction was most likely caused by the fiberwire suture as traces of the suture material were found in the macrophages.The patient had to visit the hospital and some stiffness in the wrist on flexion/extension remained but pain was gone and the patient has been discharged.

• Brand Name: SUTR ANCH MINI BC S-TAK 2.4X 8.5MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10666754
• Report Number: 1220246-2020-02224
• Device Sequence Number: 2990881
• Product Code: MAI
• UDI-Device Identifier: 00888867010147
• UDI-Public: 00888867010147
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140855
• 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
• Report Date (Section B): 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: SUTR ANCH MINI BC S-TAK 2.4X 8.5MM
• Device Catalogue Number: AR-1322BCNF
• Device Lot Number: 10148818
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/12/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other