MAUDE Adverse Event Report: DEPUY MITEK LLC US ANTEROMEDIAL FEMORAL AIMER 6.5MM -NS; ORTHOPAEDIC IMPLANT AIMING/GUIDING BLOCK

Catalog Number	254686
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	09/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The lot number is unknown.
Event or Problem Description
It was reported by the sales rep via phone that during an acl procedure when using the beath pin in the customer's rigidloop disposable system metal shavings were created.The surgeon stopped using the pin and removed the metal shavings with the suction from the shaver.The surgeon opened another rigidloop disposable system started to use the beath pin and halfway into using the pin it was noticed that metal shaving were created.This is when they realized that the customer's anteromedial femoral aimer 6.5mm that was being used with the pins has a spur on it causing the pins to create metal shavings.The surgeon removed the metal shavings again with the suction from the shaver.The procedure was completed with another aimer and the second disposable system.There was no patient harm but there was a five minute surgical delay to the case.The sales rep confirmed that there was no debris left in the patient.The sales rep could not provide a lot number for the aimer.The disposable systems were discarded by the customer but the aimer will be returning for evaluation.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary : the device was received for evaluation.Visual inspection under magnification doesn¿t show any chips or burrs in the tool that would indicate that metal shavings have come from the device.The device looks worn but is in as expected condition.This complaint cannot be confirmed no further information regarding the cause of the defect has been provided to help determine a root cause for this failure.Also, no lot number was provided to depuy mitek, therefore no device history record review could be performed.At this point in 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 as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).

• Brand Name: ANTEROMEDIAL FEMORAL AIMER 6.5MM -NS
• Common Device Name: ORTHOPAEDIC IMPLANT AIMING/GUIDING BLOCK
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9169067
• Report Number: 1221934-2019-58866
• Device Sequence Number: 16792406
• Product Code: LXH
• UDI-Device Identifier: 10886705013678
• UDI-Public: 10886705013678
• Combination Product (Y/N): N
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 11/01/2019
• Patient Sequence Number: 1