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

Catalog Number	213709
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2014
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 evaluated.The threads of the thumb screw snapped off and were stuck inside the guide, causing the 9mm rod to be stuck in the guide as well.This failure is due to the thumb screw/guide old age and wear, the 9mm rod functions appropriately without defect.No further action is warranted for this specific device.A batch review was not conducted because the batch number for this device is unknown.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.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
The sales rep reported the thumbscrew on the customer's rigidfix btb guide broke off while the surgeon was tightening the thumbscrew to secure the femoral rod in the guide during an acl procedure.The surgeon still used the guide to complete the procedure with no patient consequences or delays.The threads of the thumbscrew are stuck in the guide also making the rod stuck in the guide.The entire guide with the rod stuck in the device are coming back for evaluation.Due to this, the entire guide and the rod were replaced for the customer.The sales rep did not have lot numbers but verified the devices were over 4 years old.

• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7879942
• Report Number: 1221934-2018-54152
• Device Sequence Number: 2347511
• Product Code: FZX
• UDI-Device Identifier: 10886705003037
• UDI-Public: 10886705003037
• 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): 05/22/2014

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: 06/03/2014
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2014
• Initial Report FDA Received Date: 09/17/2018
• Patient Sequence Number: 1