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

Catalog Number 210133

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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.Visual observation reveals a number of anomalies.The locking pins on the trocar are sheared off, confirming this complaint.The distal end of the trocar is heavily damaged which is consistent with the trocar hitting the side of the femoral rod.There was scoring on the surface and inside both the sleeves indicating the fit between the sleeves and the guide frame was not tight.It is possible the nut was not tightened all the way on the metal plate of the guide frame or was loosened during the use.One of the sleeves had a bent hub and the trocar would not fit inside the sleeve anymore.It was reported that the patient had hard bone making it difficult to use the devices.From the anomalies observed, we determine the quality of the bone and user technique to be the root cause of this failure.A batch record review has been conducted for this batch 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 was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed 4 dissimilar complaints for this lot of devices that were released to distribution.Based on the overall complaint rate for this failure mode, 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).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 Description

The sales representative reported that during an anterior cruciate ligament (acl) procedure which was performed during the first week of april the trocar wings sheared off of the customer's 3.3mm rigidfix crosspin kit.The sleeve was not turning and the patient had hard bone causing the wings to break.Nothing fell into the patient and there were no patient consequences.

• 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: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7634919
• MDR Text Key: 112327269
• Report Number: 1221934-2018-51041
• 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: 04/25/2013

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
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2013
• Device Catalogue Number: 210133
• Device Lot Number: 3444045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2013
• Initial Date FDA Received: 06/25/2018
• Date Device Manufactured: 08/03/2010
• 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