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

Model Number	BIO-INTERFERENCE SCREW
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The device was reported to have been discarded.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that a ar-1370b screw was used during "a" acl surgery and removed because it was broken.There was no harm for the patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Information was requested if all broken off parts could be removed.Update 02 january 2019: the screw broke into the femur during the first turns without excessive force.The surgeon then realized that the screwdriver was not at the bottom of the screw because it was blocked.It was not possible to remove the broken fragment.

• 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: 8270464
• Report Number: 1220246-2019-00858
• Device Sequence Number: 16568791
• Product Code: MAI
• UDI-Device Identifier: 00888867014626
• UDI-Public: 00888867014626
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2019

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: 06/30/2020
• Device Model Number: BIO-INTERFERENCE SCREW
• Device Catalogue Number: AR-1370B
• Device Lot Number: 10227416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 01/23/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other