MAUDE Adverse Event Report: ARTHREX INC. IMPLANT SYSTEM, MPFL, BIOCOMPOSITE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-1360C-CP
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, 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.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as 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.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 reported that the mpfl driver was unavailable during surgery but the surgeon proceeded with another driver to insert the screw instead with the shaft retracted (ar-1540db).The surgeon struggled to insert the screw because he only used the tip of the driver to implant.The acute angle x-ray template was not used.Screw was inserted and the patient was stable immediately post-op.A revision surgery was necessary due to instability, the interference screw was found broken at proximal end.The tip will remain inside the patient.
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, 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.This is a follow-up submission due to device evaluation.Device history record review revealed nothing relevant to this event.Complaint confirmed.The evaluation revealed that the bio-composite interference screw was broken-off near the proximal threads.Additionally, the screw's internal drive was stripped.The observed damages were most likely caused due to the incorrect driver being used as stated in the event description.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 reported that the mpfl driver was unavailable during surgery but the surgeon proceeded with another driver to insert the screw instead with the shaft retracted (ar-1540db).The surgeon struggled to insert the screw because he only used the tip of the driver to implant.The acute angle x-ray template was not used.Screw was inserted and the patient was stable immediately post-op.A revision surgery was necessary due to instability, the interference screw was found broken at proximal end.The tip will remain inside the patient.

• Brand Name: IMPLANT SYSTEM, MPFL, BIOCOMPOSITE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6989810
• Report Number: 1220246-2017-00408
• Device Sequence Number: 18994824
• Product Code: MAI
• UDI-Device Identifier: 00888867014015
• UDI-Public: 00888867014015
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2017

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: 10/01/2018
• Device Catalogue Number: AR-1360C-CP
• Device Lot Number: 10075237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 10/31/2017
• Supplement Report FDA Received Date: 12/13/2017
• 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