MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEMROD B/T/B 11MM *EA; BONENAIL GUIDEWIRE

Catalog Number	213711
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation statement: the complaint device was received and evaluated.Visual observation confirms that the femoral rod is stuck on the guide frame and the thumb screw is broke.However the broken thumbscrew is not returned.This type of failure is typically observed when the thumbscrew is tightened too much causing it to snap and break when external force is applied such as malleting in this case.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 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 remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The sales rep reported the thumbscrew on the customers rigidfix btb femoral guide frame broke off while malleting into the device during an acl procedure.He stated this caused the customers rigidfix btb femoral 11mm rod to get stuck in the device and could not be removed.The surgeon was finished with the device at this point of the procedure and complete the case with no patient consequences or delays.

• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7687412
• Report Number: 1221934-2018-51298
• Device Sequence Number: 13611683
• Product Code: FZX
• UDI-Device Identifier: 10886705003051
• UDI-Public: 10886705003051
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/25/2013

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: 213711
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2013
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2013
• Initial Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1