MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEMORAL ROD 9MM 1PK; 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	07/23/2013
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 reveals the thumb screw was broken and the femoral rod is stuck inside the guide frame, confirming this complaint.It is possible that the screw was excessively tightened during procedure causing it to snap.Other than this possibility, we cannot discern a root cause for this failure.Although age of the device is unknown, it appears to be old and is in worn condition.This failure can be attributed to fair wear and tear.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 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.
Event or Problem Description
The sales representative reported that the customer's soft tissue rigidfix guide and 9' rigidfix rod became stuck together when the surgeon was performing an acl repair.The sales representative reported that when the surgeon was unscrewing the thumbscrew at the end of the procedure the screw broke in his hand.The surgeon completed the procedure with no patient consequences or delay.The sales representative could not provide the lot number or age of the devices.

• Brand Name: RIGIDFIX FEMORAL ROD 9MM 1PK
• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7677775
• Report Number: 1221934-2018-51134
• Device Sequence Number: 16532572
• Product Code: FZX
• UDI-Device Identifier: 10886705003037
• UDI-Public: 10886705003037
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 07/23/2013

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: 213709
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2013
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2013
• Initial Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1