MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH, BIO-COMP P-LCK, 2.4 X 11.3; SCREW, FIXATION, BONE

Model Number	SUTR ANCH, BIO-COMP P-LCK, 2.4 X 11.3
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2019
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 discovered via facility medwatch report ((b)(4)) that the following incident occurred: while attempting to insert the anchor for the labral repair it dislodged upon insertion and could not be found visually with the arthroscope.Another anchor was open and utilized correctly to complete the procedure.The initial anchor that was dislodged was not found and remained in the patient.Arthrex anchor was a bio-composite pushlock 2.4 x 11.3mm (expiration date 04/30/2021, reference number ar-2922bc.Surgery was completed with no further complications, dressings applied and patient was taken to pacu.Additional information obtained from the facility clinical risk specialist: the date of the procedure was (b)(6) 2019.It is possible the device may have been suctioned out by the neptune device however they were unable to confirm this.The device could still be in the patient.

• Brand Name: SUTR ANCH, BIO-COMP P-LCK, 2.4 X 11.3
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9287380
• Report Number: 1220246-2019-01398
• Device Sequence Number: 14031240
• Product Code: HWC
• UDI-Device Identifier: 00888867197664
• UDI-Public: 00888867197664
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/06/2019

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: SUTR ANCH, BIO-COMP P-LCK, 2.4 X 11.3
• Device Catalogue Number: AR-2922BC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other