MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEM GDEFR B/T/B *EA; BONENAIL GUIDEWIRE

Catalog Number	213702
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation statement the product is not being returned, it has been discarded by the customer.We attribute the product's condition to fair wear & tear due to age and use as it is over 4 years old.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.At this point in time, no corrective action is required and 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) - incomplete.Depuy mitek has been informed that the lot number is not available.This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the sales rep that during an acl repair that the pin on the customer's rigidfix guide frame broke as the surgeon was malleting the frame up.The sales rep reported that this caused the femoral rod 10mm to become stuck inside the guide frame.The surgeon completed the procedure with another like device with no patient consequences or delay.The sales rep could not provide the lot numbers but stated the devices were over 4 years old.The devices were discarded.

• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7690083
• Report Number: 1221934-2018-51053
• Device Sequence Number: 1120511
• Product Code: LXH
• UDI-Device Identifier: 10886705002962
• UDI-Public: 10886705002962
• 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): 06/19/2013

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: 213702
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2013
• Initial Report FDA Received Date: 07/16/2018
• Patient Sequence Number: 1