MAUDE Adverse Event Report: DEPUY MITEK RIGIDFIX FEMORAL ROD 10 MM 1PK; BONENAIL GUIDEWIRE

Catalog Number	213710
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2015
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.The complaint device was received and inspected.Visual observation indicates the thumbscrew was broken, but no anomalies with the femoral rod.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.(b)(4).The serial number is currently unavailable.(b)(4).
Event or Problem Description
This is report 2 of 2 for the same event.It was reported by the sales rep that at the end of an anterior cruciate ligament (acl) surgical procedure, it was observed that the thumbscrew on the customer rigidfix btb guideframe broke off causing their femoral rod, 10 mm to become stuck inside the guideframe.The happened at the end of the procedure when the device was being removed.The sales rep reported that the surgeon had completed the procedure with no patient consequences or delays.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.

• Brand Name: RIGIDFIX FEMORAL ROD 10 MM 1PK
• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7788409
• Report Number: 1221934-2018-54505
• Device Sequence Number: 1808778
• Product Code: FZX
• UDI-Device Identifier: 10886705003044
• UDI-Public: 10886705003044
• 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
• Report Date (Section B): 08/03/2015

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: 213710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2015
• Initial Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE FRAME DEVICE