MAUDE Adverse Event Report: ARTHREX INC. 11.0 MM FLIP CUTTER II; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	AR-1204AF-110
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2017
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.This is one of three submissions from the same case.The others are cc130078-line 213291-00455 and cc130078-line 213292-00456.The device was received and an evaluation was conducted.Device history record review revealed nothing relevant to this event.The evaluation revealed that the shaft's distal end was cut-off.The shafts were slightly bent.The device met all material specifications as received.However, the cut-off portion with the broken-off end was not returned for evaluation; therefore, the complaint cannot be verified.Complainant's event typically caused by user mechanical damage to device such as hitting the device with another device, prying/leveraging or excessive bending forces being applied during use.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 during an acl procedure three different flip cutter ii's were attempted (ar-1204af-100: lot 415148483 {line 213291}, lot 74071209 {line 213292} and ar-1204af-110: lot 62316678 {line 213294}) and each broke intra-articular when starting the blind tunnel.Broken fragments were all reported to have been retrieved.The surgical technique was changed from an acl to an arthrotomy and the surgery was completed successfully using another manufacturer's device.

• Brand Name: 11.0 MM FLIP CUTTER II
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7074414
• Report Number: 1220246-2017-00457
• Device Sequence Number: 19109663
• Product Code: MDM
• UDI-Device Identifier: 00888867004139
• UDI-Public: 00888867004139
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• 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): 12/01/2017

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: 07/01/2021
• Device Catalogue Number: AR-1204AF-110
• Device Lot Number: 623166788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/01/2017
• 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