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

Catalog Number	AR-1915SF-1
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was received and an evaluation was conducted.The complaint was confirmed.Device history record review revealed nothing relevant to this event.The evaluation revealed that the proximal hex portion of the anchor was broken-off, and is lodged inside the distal tip of the driver.The fracture surface displays evidence of torsional-overload.The complainant's event typically caused by over insertion and or prying/leveraging the driver while the implant is still loaded and or improper bone preparation.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that the anchor broke during insertion.It was not possible to remove the broken fragment.The surgery was completed successfully with a new device of the same part number.There was no harm for patient, user or third party.Performed surgery was an arthroscopic biceps tenodesis.

• Brand Name: SUTURE ANCHOR,CORKSCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7266944
• Report Number: 1220246-2018-00034
• Device Sequence Number: 11176569
• Product Code: HWC
• UDI-Device Identifier: 00888867022669
• UDI-Public: 00888867022669
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 01/13/2018

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: 05/01/2022
• Device Catalogue Number: AR-1915SF-1
• Device Lot Number: 10147347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/13/2018
• 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