MAUDE Adverse Event Report: DEPUY MITEK LLC US ANTEROMEDIAL FEMORAL AIMER, 5.5MM -NS; ORTHOPAEDIC IMPLANT AIMING/GUIDING BLOCK

Catalog Number	254672
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was received and evaluated.The device was observed under a microscope and confirmed there are nicks, slight discoloration and missing pieces of metal found at the opening near the distal tip of the shaft.The device appears in used condition.The friction marks indicate excessive force caused by the lack of irrigation fluid, therefore this failure can be attributed to inadequate amount of fluid used.A device history record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices with the product code that were released to distribution.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.(b)(4).
Event or Problem Description
It was reported by the sales rep via phone that during an acl procedure the customer's anteromedial femoral aimer created metal shavings in the patient's joint space.The sales rep could not confirm if all the metal shavings were removed from the joint space.The procedure was completed with another like device with a five minute delay to swap out the device.The sales rep was not present for the case therefore could not provide any further information.The device will be returning for evaluation.

• Brand Name: ANTEROMEDIAL FEMORAL AIMER, 5.5MM -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: 7574618
• Report Number: 1221934-2018-51413
• Device Sequence Number: 283341
• Product Code: LXH
• UDI-Device Identifier: 10886705013548
• UDI-Public: 10886705013548
• 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,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2018

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 Catalogue Number: 254672
• Device Lot Number: 1706001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 06/06/2018
• 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