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

Catalog Number	213709
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The lot number is currently unavailable.The complaint device was received and evaluated.Visual observation revealed that the thumbscrew was broken confirming this complaint.The femoral rod was stuck inside the guide frame and cannot be separated.The laser lines were also significantly faded.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 etq complaint management system 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 surgical procedure, it was observed that the thumb screw on their rigidfix femoral btb guide frame broke and their rigidfix femoral rod 9mm was stuck in the guide frame.The sales rep stated that where the device broke was outside the patient.The sales rep reported that the surgeon had completed the procedure with the device before the device failure occurred.The sales rep reported that there were no patient consequences or delays in the case.The sales rep could not provide lot numbers for the devices but stated that the guide frame was less than a year old and the rod was approximately four years old, both devices have seen heavy use in the field.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The lot number is currently unavailable.The complaint device was received and evaluated.Visual observation revealed that the thumbscrew was broken confirming this complaint.The femoral rod was stuck inside the guide frame and cannot be separated.The laser lines were also significantly faded.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 etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.Associated medwatch: 1221934-2018-51917.

• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8246131
• Report Number: 1221934-2019-55998
• Device Sequence Number: 13941440
• Product Code: FZX
• UDI-Device Identifier: 10886705003037
• UDI-Public: 10886705003037
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 04/15/2016

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: 05/23/2016
• Initial Date Received by Manufacturer: 04/15/2016
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1