MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEM 3.3MM S/T XPIN; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 210133

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2017

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The complaint devices were received and evaluated.Visual observation confirms that the sleeves and trocars are welded together.It was observed that the outer surface of the sleeves had striations on it indicating that it was loosely fit inside the guide frame.Historically, there are a couple of known factors that have been observed which could have caused or contributed to this type failure mode: if the pins on the trocar are not fully seated in the sleeve prior to the rotation of the trocar.If there is pressure applied to the side of the system (not drilling in line), and another factor is if the frame is out of straightness.All of these factors will cause the frame to bind with the sleeve/trocar resulting in welding of the two parts.This failure can be attributed to user technique.A dhr review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed no other similar complaint of any kind for this lot of devices that were released to distribution.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 Description

This is report 4 of 4 for the same event.It was reported by the sales rep that the customer's rigidfix femoral 3.3mmst cross pin kit, rigidfix femoral st guide frame, rigidfix femoral/tibial rod thumb screw failed during an anterior cruciate ligament acl reconstruction surgical procedure.It was reported that the surgeon placed the guide frame in and they binded up then cold welded but was unable to take apart.The surgeon stated that all of the devices looked too big and not working correctly.The case was completed with another like device.There were no adverse patient consequences or time delay.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 FEM 3.3MM S/T XPIN
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 8271376
• MDR Text Key: 134738430
• Report Number: 1221934-2018-53278
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 10886705000890
• UDI-Public: 10886705000890
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 210133
• Device Lot Number: 3838897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1