MAUDE Adverse Event Report: ARTHREX, INC. BIOCOMPOSITE INTER- FERENCE SCREW; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIOCOMPOSITE INTER- FERENCE SCREW
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/27/2017
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 disposition is unknown.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that on the (b)(6) 2015 a replacement of the cruciate ligament surgery took place.The surgeon did the transfix technique with semitendinosis tendon and placed tibial the biocomposite interference screw for fixation.After surgery the patient complaint about post-operative pain (date of complaint by patient unknown).The customer performed a magnetic resonance imaging which revealed a broken fragment of the screw which is not fixed into the bone.(the facility cant provide pictures of the mri) the surgeon decided on a arthroscopic revision surgery to remove the broken fragment.The revision took place on the (b)(6) 2017.

• Brand Name: BIOCOMPOSITE INTER- FERENCE SCREW
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7832226
• Report Number: 1220246-2018-00614
• Device Sequence Number: 13948329
• Product Code: MAI
• UDI-Device Identifier: 00888867016163
• UDI-Public: 00888867016163
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/30/2018

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 Model Number: BIOCOMPOSITE INTER- FERENCE SCREW
• Device Catalogue Number: AR-1400C
• Device Lot Number: UNK1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 08/30/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other