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

Catalog Number	AR-1915SF
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 anchor is broken-off at the transition between the hex and threaded portion.The anchor body was not returned.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.This is the first complaint of this type for this part/lot combination.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 midway through a total knee arthroplasty case, the tip of the corkscrew suture anchor broke-off into the patient's knee.Per reporter, the surgeon stated that it would cause more damage to try and retrieve the tip rather than just leaving it in.The tip of the anchor was left in the patient.The case was completed with no further incident.Patient is a female, age (b)(6), weighing (b)(6).Follow-up investigation: date of surgery was (b)(6) 2017.Device portion that did not remain in patient has been returned for evaluation.Patient surgery was an open procedure and no additional incisions were made.A corkscrew anchor was being used during the total knee arthroplasty case because the patella tendon was severed and needed to be repaired.The surgeon attempted to repair the patella tendon with the suture anchor.

• 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: 7027717
• Report Number: 1220246-2017-00431
• Device Sequence Number: 927934
• Product Code: HWC
• UDI-Device Identifier: 00888867022652
• UDI-Public: 00888867022652
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2017

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: 11/01/2021
• Device Catalogue Number: AR-1915SF
• Device Lot Number: 10081373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/14/2017
• 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
• Patient Age: 43 YR
• Patient Weight: 53