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

Catalog Number	AR-1370C
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, 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 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.Device history record review revealed nothing relevant to this event.Complainant's event is typically caused by not inserting the implant co-axial to the bone tunnel, implant not being seated properly on the driver, prying or leveraging while still loaded, improper bone preparation or flexing the joint during insertion.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.Device remains in patient.
Event or Problem Description
It was reported that during a double bundle pcl procedure, the surgeon attempted to load two ar-1360c bio-comp interference screws, lot 1240135 ((b)(4)), on the driver but neither would attach to the driver.The surgeon then opened an ar-1370c, bio-comp interference screw, lot 1216490 ((b)(4)), and the tip of the ar-1370c broke-off into the bone tunnel.The surgeon removed the screw tip as best he could by drilling it with a guide pin.It is possible some fragments remained in the bone tunnel.In the process of removing the screw, the graft was damaged and eventually tore in half when placing a second ar-1370c from same lot.This second ar-1370c was left in the tunnel.To complete the case the surgeon opened two ar-1360c-cp kits, lot 10048527 and lot 300520.Surgeon used the 6x23 screws from the kits and ended up using one bundle of the double bundle graft instead of two to complete the case since the other was damaged.

• Brand Name: BIO-COMP. 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: 6030724
• Report Number: 1220246-2016-00423
• Device Sequence Number: 912325
• Product Code: MAI
• UDI-Device Identifier: 00888867014633
• UDI-Public: 00888867014633
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2016

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: 09/01/2016
• Device Catalogue Number: AR-1370C
• Device Lot Number: 1216490
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2016
• Initial Report FDA Received Date: 10/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR-1360 LOT 1240135 BIO-COM. INTERFERENCE SCREW; AR-1360C-CP LOT 10048527 IMPLANT SYS MPFL BIO-COMP; AR-1360C-CP LOT 300520 IMPLANT SYS. MPFL BIO-COMP
• Outcome Attributed to Adverse Event: Other