MAUDE Adverse Event Report: ARTHREX, INC. BIO-INTERFERENCE SCREW; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-5035TB-09
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (date of birth, 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 met dimensional specifications as received.The evaluation revealed that the returned screw is broken in half with a damaged tip and threads.At this time, the cause is undetermined as to why the screw broke post-op after 3 months of implantation.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 an acl was performed on (b)(6) 2016 with a 5x50 arthrex biodegradable and arthrex biodegradable interference screw.The patient started with pain and the surgeon intervened on (b)(6) 2016 for a revision where we found the biodegradable interference screw split in two parts.One arthroscopy and one open part was removed and a new interference was placed, this time titanium (10x30 arthrex).Patient: (b)(6) male.Patient is stable and doing fine.

• Brand Name: BIO-INTERFERENCE SCREW
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6150569
• Report Number: 1220246-2016-00543
• Device Sequence Number: 407628
• Product Code: MAI
• UDI-Device Identifier: 00888867035461
• UDI-Public: 00888867035461
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K062466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 12/07/2016

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: 03/01/2017
• Device Catalogue Number: AR-5035TB-09
• Device Lot Number: 1277230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2016
• Initial Report FDA Received Date: 12/07/2016
• 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: 20 YR