MAUDE Adverse Event Report: ARTHREX, INC. SUTURETAPE FIBERLINK 1.3MM WH/BL; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	SUTURETAPE FIBERLINK 1.3MM WH/BL
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2020
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 the surgeon was performing a revision shoulder arthroscopy, revising a previous labral repair by cutting and shaving out previously implanted suturetape fiberlink.During the process the inner blade partially broke but it is still attached.This caused the outer blade to become notched and the shaver to lock up.There was no retained material inside the patient.The procedure was completed using a more aggressive shaver (4.0 excalibur).Additional information obtained 07/28/2020: the patient had a labral repair surgery sometime in (b)(6) 2019 to repair a buford complex.The revision was being performed due to over tightening of the shoulder.The specific arthrex product used in the original procedure, the original procedure surgeon name and facility are all unknown and have not been provided by the revising surgeon.The specific products original implanted are not known.However the sales rep who was present during the revision states the part is believed to be ar-7535.The anchor bodies and eyelet were not removed during the revision procedure.Just the suturetape fiberlink from the anchors was cut and shaved out.Reporter states the device did not hit bone or another instrument during use.Dualwave inflow only tubing was being used during the procedure and there was no interruption of irrigation flow through the device during its use.

• Brand Name: SUTURETAPE FIBERLINK 1.3MM WH/BL
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10393442
• Report Number: 1220246-2020-02024
• Device Sequence Number: 3528936
• Product Code: GAT
• UDI-Device Identifier: 00888867288669
• UDI-Public: 00888867288669
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K171296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2020

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: SUTURETAPE FIBERLINK 1.3MM WH/BL
• Device Catalogue Number: AR-7535
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 08/11/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other