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	No Code Available (3191)
Date of Event	03/15/2018
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 30 months after a initial successful scapholunate ligament repair for the scaphoid an lunate significant lysis was found around both suturetaks, especially around the lunate one.The surgeon reported in addition that an oedema in the capitate bone and signs of osteoarthritis in the midcarpal bones were identified which were not expected following a scapholunate ligament repair.The surgeon stated the assumption that the lysis around the suturetaks in the scaphoid and lunate has had a knock-on effect with the adjacent bones.It was further reported that the ligament repair itself looked well.Currently it is unknown if a revision surgery is necessary.

• 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: 10634180
• Report Number: 1220246-2020-02215
• Device Sequence Number: 16826282
• 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): 10/06/2020

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 Model Number: SUTR ANCH MINI BC S-TAK 2.4X 8.5MM
• Device Catalogue Number: AR-1322BCNF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/06/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other