MAUDE Adverse Event Report: ARTHREX, INC. FIBERSTITCH IMPLANT, CURVED; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	FIBERSTITCH IMPLANT, CURVED
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/31/2019
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 reported that the surgeon was performing a lateral meniscus repair with the fiber stitch implant, ar-4570, approaching the meniscus from the lateral portal.For both devices, when he was repairing the posterior meniscus near the horn, he had lots of torque on the handle and when he tried to implant the second anchor, the tip broke off.He retrieved both tips and nothing was left in the patient.Although the user put torque on the device, it was interesting to note that the device broke in the same spot on both tips.Additional information provided 1/3/2019: the first implants from both devices remained behind the capsule with the suture cut-off from the implant.

• Brand Name: FIBERSTITCH IMPLANT, CURVED
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9607430
• Report Number: 1220246-2020-01590
• Device Sequence Number: 2677163
• Product Code: MBI
• UDI-Device Identifier: 10818674021798
• UDI-Public: 10818674021798
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K190125
• 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): 01/20/2020

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: 04/30/2024
• Device Model Number: FIBERSTITCH IMPLANT, CURVED
• Device Catalogue Number: AR-4570
• Device Lot Number: 19N03
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/20/2020
• 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