MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEMROD S/T 8MM *EA; BONENAIL GUIDEWIRE

Catalog Number	213708
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2015
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.Evaluation statement: the complaint device was received and evaluated.The slotted area of the distal tip is cut and warped, confirming this complaint.The root cause of this complaint is heavy use and drilling against the sides of the slot.A batch review was not done as the batch information was not provided.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.This report is being filed from (b)(4) as required under mitek¿s corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
The sales representative reported that the customers rigidfix femoral rodd 8mm is worn at the tip area, and the 7mm rigidfix femoral rod was warped at the tip.The surgeon was able to complete the procedure using other like devices, with no delay and no patient consequences.

• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8102424
• Report Number: 1221934-2018-53479
• Device Sequence Number: 13852691
• Product Code: FZX
• UDI-Device Identifier: 10886705003020
• UDI-Public: 10886705003020
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 213708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2015
• Initial Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1