MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PEEK PUSHLOCK; SCREW, FIXATION, BONE

Model Number SUTURE ANCHOR, PEEK PUSHLOCK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Autoimmune Disorder (1732); Death (1802); Hemorrhage/Bleeding (1888); Thrombus (2101)

Event Date 06/30/2020

Event Type  Injury  

Manufacturer Narrative

The surgeon provided the information that the patient's disease is most likely caused by an acute (b)(6) 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 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 bio-composite anchors and two (2) swivelock bio-composite 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 (b)(6) 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, PEEK PUSHLOCK
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 10358065
• MDR Text Key: 203465566
• Report Number: 1220246-2020-01996
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00888867023147
• UDI-Public: 00888867023147
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K061863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: SUTURE ANCHOR, PEEK PUSHLOCK
• Device Catalogue Number: AR-1923PS
• Device Lot Number: 10263269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 08/03/2020
• Date Device Manufactured: 12/17/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR