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

Catalog Number	213708
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4)-incomplete.The lot number is currently unavailable.The complaint device was received and inspected.Visual observation indicates the thumbscrew was broken confirming this complaint.The femoral rod is stuck inside the guide frame and cannot be separated.It is possible that the screw was excessively tightened on the guide frame causing fatigue and eventually breaking it.The device appears to be old and worn and thus it is also a possibility that this failure was a result of worn components.Furthermore, no lot number was 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 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.This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
This is report 2 of 2 for the same event.It was reported by the sales rep that during an anterior cruciate ligament acl reconstruction surgical procedure, after removing the soft tissue u-shaped guide from the patient's knee, the tech in the back table tried to unscrew the 8mm rod from the soft tissue guide and the bolt that holds both guides together broke off; leaving the 8mm guide attached to the soft tissue guide.Tourniquet time was not affected from the norm.The guide was no longer needed during that case.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8266721
• Report Number: 1221934-2018-52811
• Device Sequence Number: 16600754
• Product Code: FZX
• UDI-Device Identifier: 10886705003020
• UDI-Public: 10886705003020
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/17/2016

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: 12/22/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2016
• Initial Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1