MAUDE Adverse Event Report: DEPUY MITEK LLC US 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	06/05/2014
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 evaluated.From visual inspection it is shown the threads of the thumb screw have broken off inside the guide, trapping the 10 mm femoral rod secured in the guide.Other than this, the 10 mm guide functions properly without any defect.This failure can be attributed to the guide's old age and heavy use and no failure is attributed to the femoral rod.A batch review was not conducted as the batch number 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).
Event or Problem Description
Before the case, scrub technician complained of the rigidfix system screw being weak.Intraoperatively, while malleting the rigidfix system into the femoral tunnel, the screw broke in half.The 10 mm rigidfix guide is stuck in the bone tendon bone rigidfix guide.We were able to complete surgery with no delay.

• Brand Name: RIGIDFIX FEMORAL ROD 10 MM 1PK
• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7713718
• Report Number: 1221934-2018-52046
• Device Sequence Number: 16472675
• Product Code: FZX
• UDI-Device Identifier: 10886705003044
• UDI-Public: 10886705003044
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/05/2014

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: 213710
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2014
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2014
• Initial Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1