MAUDE Adverse Event Report: ARTHREX INC. BIO-COMPOSITE CORKSCREW FT VENTED 5.5X14.7MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-1927BCNF
Health Effect - Clinical Code	Weight Changes (2607)
Date of Event	03/21/2018
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.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation 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.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 by the sales rep that during a patella tendon reconstruction procedure, after the surgeon drilled the patient's bone, as the surgeon was inserting the two ar-1927bcnf biocomposite corkscrew anchors (ft vent 5.5 x 14.7 mm) the anchors broke.About 6 threads broke-off each, flush (if not a little countersunk).The eyelet and sutures held in place and the internal brace held the repair.The anchor was seated at 16.5 mm and the patient's bone was very dense.A suture tape was used to help protect repair in case the remaining part of the anchor eventually migrated out and two internal braces were incorporated to augment the repair.Patient was a (b)(6).Follow-up investigation: the distal portion of the anchors which remained in the patient are approximately 8 mm.The proximal ends of the anchors are not being returned because they were fractured in multiple pieces (approximately 8 pieces total) and thrown into the biohazard bin.

• Brand Name: BIO-COMPOSITE CORKSCREW FT VENTED 5.5X14.7MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7467828
• Report Number: 1220246-2018-00148
• Device Sequence Number: 16406881
• Product Code: MAI
• UDI-Device Identifier: 00888867023406
• UDI-Public: 00888867023406
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 04/27/2018

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: 05/01/2019
• Device Catalogue Number: AR-1927BCNF
• Device Lot Number: 10142713
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 04/27/2018
• 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
• Patient Age: 30 YR
• Patient Weight: 103