MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX CURVE ACL ST PLA CROSS PIN KIT; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	213013
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2014
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.The complaint device was received and evaluated.Visual observation confirms that the sleeve and trocar are welded together.It was observed that the outer surface of the sleeve 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.The next generation rigidfix cross pin kit addresses these challenges with an enhanced design that provides a compact fit between the sleeve and trocar inside the guide frame.A batch record 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 mitek complaints system revealed no other complaints for this lot of (b)(4) devices that were released to distribution.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.Udi: (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 or Problem Description
It was reported by the affiliate in (b)(6) that during anterior cruciate ligament (ac) repair surgical procedure, it was observed that the sleeve components broke off during drilling.The procedure was completed with same like product.There was a delay of 10 minutes in the surgical procedure.It was reported that nothing fell into the patient.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 CURVE ACL ST PLA CROSS PIN KIT
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7806248
• Report Number: 1221934-2018-52233
• Device Sequence Number: 11085356
• Product Code: HTY
• UDI-Device Identifier: 20886705020000
• UDI-Public: 20886705020000
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K130105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2014

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 Expiration Date: 07/01/2016
• Device Catalogue Number: 213013
• Device Lot Number: 3716565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2014
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2014
• Initial Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1