MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEMROD 9MM *EA; BONENAIL GUIDEWIRE

Catalog Number	213709
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2014
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 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 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
The sales representative reported that during an acl repair that the thumbscrew broke off his rigidfix st u guide when the surgeon was malleting the device in.The surgeon completed the procedure with the device with no patient consequences or delay.The 9mm rod was not able to be removed from the guideframe and will be returned with the complaint device.The sales representative could not provide a lot number for the devices but reported that they were over three (3) years old.

• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8054873
• Report Number: 1221934-2018-52805
• Device Sequence Number: 1747874
• Product Code: FZX
• UDI-Device Identifier: 10886705003037
• UDI-Public: 10886705003037
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/05/2014

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: 213709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2014
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2014
• Initial Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1