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

Catalog Number	AR-1915SF-1
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/21/2016
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 requested for evaluation but was not returned therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be 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 anchor broke during insertion in the proximal patella.Surgery performed was an acl and quadriceps tendon re-fixation.Fragment could not be retrieved and remains in patient's body.Surgery was successfully completed using another device of the same part number.According to surgeon, fragment does not affect patient negatively, fragment is not prominent.
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.This is a follow-up submission to reflect device evaluation.Complaint confirmed.The evaluation revealed that the anchor is broken-off at the transition between the hex and threaded portion of the anchor.The fracture surface displays evidence of torsional-overload.The device met all material specifications as received.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.
Event or Problem Description
It was reported that anchor broke during insertion in the proximal patella.Surgery performed was an acl and quadriceps tendon re-fixation.Fragment could not be retrieved and remains in patient's body.Surgery was successfully completed using another device of the same part number.According to surgeon, fragment does not affect patient negatively, fragment is not prominent.

• 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: 6184916
• Report Number: 1220246-2016-00564
• Device Sequence Number: 18842866
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2017

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: 04/01/2020
• Device Catalogue Number: AR-1915SF-1
• Device Lot Number: 1554944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 01/06/2017
• 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