MAUDE Adverse Event Report: DEPUY MITEK LLC US RESTORE FEMAIMER OFFSET 7MM *EA; ORTHOPAEDIC IMPLANT AIMING/GUIDING BLOCK

Catalog Number	219357
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device was received and evaluated.Visual observation confirms the distal tip is broken.This device is made of stainless steel and from past investigations it has been determined that this type of failure can be observed with applying excess force while using the device.Other than this possibility, a root cause cannot be determined.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Based on the complaint history for this failure, at this point in time, no further action is warranted.However, depuy 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
The sales rep reported that during an acl procedure the distal tip of their femoral aimer 7 mm offset broke off.The sales rep stated that they had believed that the device broke in the patient; they searched the joint space for the broken tip and could not find the broken piece.The sales rep reported the surgeon completed the procedure with an arthrex guide with no patient consequences but there was a five minute delay.She reported that after the procedure was completed x-rays were performed to see if the broken piece was in the patient and the x-rays revealed that nothing left in the patient.The sales rep reported that the broken piece was found on the patient table under patient's leg outside the body.She stated that they compared the piece to the device and confirmed that is was the broken piece from the device.The sales rep could not provide the lot number for the device.The device will be returning for evaluation.

• Common Device Name: ORTHOPAEDIC IMPLANT AIMING/GUIDING BLOCK
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7750018
• Report Number: 1221934-2018-53349
• Device Sequence Number: 13883071
• Product Code: LXH
• UDI-Device Identifier: 10886705005970
• UDI-Public: 10886705005970
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2015

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: 219357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2015
• Initial Report FDA Received Date: 08/05/2018
• Patient Sequence Number: 1