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

Model Number	AR-1380TB
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/23/2017
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 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 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 originally reported that there was a thread defect and the screw broke.The surgeon was able to remove the broken fragment.The other half remained inside the patient.The surgeon confirmed that the tendon is securely fixed in the tunnel.Follow up investigation: the screw does not enter easily into the bone, but the surgeon tried anyway (with force) and so the screw broke on insertion.

• Brand Name: BIO-INTERFERENCE SCREW, FULL THREAD
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6934416
• Report Number: 1220246-2017-00369
• Device Sequence Number: 19142216
• Product Code: MAI
• UDI-Device Identifier: 00888867015340
• UDI-Public: 00888867015340
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K062466
• 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
• Report Date (Section B): 10/10/2017

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: 02/01/2019
• Device Model Number: AR-1380TB
• Device Catalogue Number: AR-1380TB
• Device Lot Number: 10125452
• 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: 09/20/2017
• Initial Report FDA Received Date: 10/10/2017
• 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