MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, BIO- COMPOSITE SUTURETAK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTURE ANCHOR, BIO- COMPOSITE SUTURETAK
Health Effect - Clinical Codes	Autoimmune Disorder (1732); Death (1802); Hemorrhage/Blood Loss/Bleeding (1888); Thrombus (2101)
Date of Event	06/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The surgeon provided the information that the patient's disease is most likely caused by an acute cytomegaly virus.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 3.5 months ago the patient, a top athlete, underwent surgery due to an extensive anterior/posterior/superior labrum injury wherein the surgeon utilized four (4) fast-tak biocomposite anchors and two (2) swivelock biocomposite anchors to complete the procedure.When the surgeon saw the patient post-operatively everything looked normal, without any issues.However, at the most recent follow up appointment the patient had developed a serious condition (bleeding, clots, etc.).The surgeon reported that it was possibly due to an immunological condition.Update 02-jul-2020: the surgeon provided the information that the patient¿s issues were most likely caused by an acute cytomegaly virus.Update 08-jul-2020: it was further reported that the surgeon actually utilized five (5) pushlocks, ar-1923ps (lot10285636 - qty 3 and lot 10263269 - qty 2) and three (3) suturetaks, ar-1934bcf (lots: 10235880, 10294553, 10283790) during the initial surgery.Update 13-jul-2020: a published article was found which stated that the patient had been hospitalized for two weeks after falling ill during training and passed away on (b)(6) 2020.The article further described that prior to passing the patient was diagnosed with an autoimmune disease.The article did not mention the prior surgery utilizing arthrex¿s anchors and to date there has been no correlation found between that surgery and the patient¿s death.

• Brand Name: SUTURE ANCHOR, BIO- COMPOSITE SUTURETAK
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10358066
• Report Number: 1220246-2020-01994
• Device Sequence Number: 2865578
• Product Code: MAI
• UDI-Device Identifier: 00888867023871
• UDI-Public: 00888867023871
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 08/03/2020

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: 02/28/2021
• Device Model Number: SUTURE ANCHOR, BIO- COMPOSITE SUTURETAK
• Device Catalogue Number: AR-1934BCF
• Device Lot Number: 10283790
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 08/03/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 27 YR