MAUDE Adverse Event Report: DEPUY MITEK RIGIDFIX PLA 3.3 MM FEMORAL ST CROSS PIN KIT; MITEK ACL IMPLANTS

Catalog Number 210133

Device Problem Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Date 10/06/2016

Event Type  Injury  

Manufacturer Narrative

The complaint device is not available for a physical evaluation.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.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.A batch record review has been conducted and 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.(b)(4).Associated medwatch: 1221934-2016-10456, 1221934-2016-10457, 1221934-2016-10458, 1221934-2016-10459.

Event Description

The sales rep reported that during an acl procedure three of the customer's rigidfix femoral 3.3mm st cross pins and two of the customer's rigidfix femoral st guide frames, when drilling the pins in the sleeve on the disposable kit the drill bit and the pins would cold weld together inside the guide frame making them unusable.The sales rep is unsure if the disposable kits or the guide frames are at fault for the issue that kept occurring.The sales rep reported that the surgeon created new bone holes each time with each device and completed the procedure with a four device by free handing the pins without a guide frame.The sales rep reported that there were no patient consequences but there was a 15 minute delay in the case.The sales rep could not provide lot numbers for the guide frames but stated that the devices are brand new and the manufacturer numbers on the guide frames do match.The sales rep stated that the patient was a (b)(46 female with average bone quality.The sales rep stated that the disposable kits were discarded and that the guide frames will be returning for evaluations.

• Brand Name: RIGIDFIX PLA 3.3 MM FEMORAL ST CROSS PIN KIT
• Type of Device: MITEK ACL IMPLANTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 6081913
• MDR Text Key: 59278608
• Report Number: 1221934-2016-10455
• Device Sequence Number: 1
• Product Code: HTY
• 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
• Type of Report: Initial
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 210133
• Device Lot Number: 3891848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2016
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2016
• 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
• Patient Outcome(s): Other