MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PEEK SWIVELOCK C; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTURE ANCHOR, PEEK SWIVELOCK C
Health Effect - Clinical Codes	Scar Tissue (2060); Reaction (2414)
Date of Event	09/09/2018
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 patient underwent a procedure on (b)(6) 2018 and is part of a shoulder arthroscopy study.The 2018 procedure was performed in (b)(6).Now patient¿s anchor is loose and a revision surgery is scheduled for (b)(6) 2019, in (b)(6) to remove the anchor.The anchor part number is ar-2323pslc, lot unknown.Update 01-apr-2019: the revision surgery on (b)(6) 2019 took place and went well.The anchor will not be returned because it remains in the patient.It turned out that the patient had an abnormal reaction to the sutures which resulted in excessive scar tissue being formed.Surgeon only removed the sutures, the anchor remains in place.Update 02-apr-2019: the scan was taken before the revision, it suggested that the anchor came loose.But during the revision surgery the surgeon didn´t see the anchor.It was covered by scar tissue, which probably gave a false image on the scan.Surgeon decided not to search for the anchor because he didn´t want to cause more damage to the cuff.

• Brand Name: SUTURE ANCHOR, PEEK SWIVELOCK C
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8526608
• Report Number: 1220246-2019-01038
• Device Sequence Number: 1885136
• Product Code: MAI
• UDI-Device Identifier: 00888867026797
• UDI-Public: 00888867026797
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K151342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2019

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: SUTURE ANCHOR, PEEK SWIVELOCK C
• Device Catalogue Number: AR-2323PSLC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 04/18/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other