MAUDE Adverse Event Report: DEPUY MITEK ANTEROMEDIAL FEMORAL AIMER 6.5MM; MITEK ARTHROSCOPIC INSTRUMENTS

Catalog Number	254686
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device was received and evaluated.Visual inspection revealed the device was extremely worn.Visual examination of the distal end of the device under magnification revealed some scratches and nicks at the edge of the inner pass.Due to the observed nicks, the complaint of metal shavings can be confirmed.This reusable device is about eight years old and has possibly seen heavy use in the field.Potential root causes for the observed damage include wear of the device or use with a pin which was slightly bent.Review of the device history record indicated that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the records reviewed.Review of the depuy synthes mitek complaints system revealed no other complaints of any type for this lot of (b)(4) devices released to distribution in 2009.At this time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.
Event or Problem Description
The sales rep reported via phone that the customer's anteromedial femoral aimer left metal shavings in the patient during an acl procedure.The metal shavings were removed from the patient and the case was completed with the device.There were no patient consequences or delays.The device is being returned.

• Brand Name: ANTEROMEDIAL FEMORAL AIMER 6.5MM
• Common Device Name: MITEK ARTHROSCOPIC INSTRUMENTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6672316
• Report Number: 1221934-2017-10324
• Device Sequence Number: 1080361
• Product Code: LXH
• UDI-Device Identifier: 10886705013678
• UDI-Public: (01)10886705013678(10)0902
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2017
• Report Date (Section F): 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 254686
• Device Lot Number: 0902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2017
• Initial Report FDA Received Date: 06/27/2017
• Patient Sequence Number: 1