MAUDE Adverse Event Report: DEPUY MITEK RAPIDLOC (PLA/PDS) 2/0 PANACRYL 12° CURVE NEEDLE; MENISCAL IMPLANTS

Catalog Number 228311

Device Problem Break (1069)

Patient Problem Surgical procedure, delayed (2565)

Event Date 02/11/2015

Event Type  Injury  

Event Description

It broke when performing the shot and got away with the adjusting device.The surgeon don´t use any product to resolve this problem.He closed without suturing.Additional information from the affiliate did all three anchors break in this procedure? yes was the insertion off axis? no.Did the patient have hard bone? no.Please explain what the surgeon did to complete the procedure.The form states he closed with suturing, please explain.The doctor closed without suturing.Pending doctor explanation did this issue extend the procedure time greater than 30 minutes? yes.Associated medwatch 1221934-2015-00655, 1221934-2015-00656.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek however it is not known if it will be received within the 30 day reporting requirement, therefore, depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.In process.

Manufacturer Narrative

The complaint devices were received and evaluated.Visual observation of the applier reveals that the pusher rod was slight bent upward.This is possibly due to forced loading/unloading of the needle.When the trigger was operated, there was slight resistance noted but fully functional.It cannot be determined at what point the pusher rod was bent.This could have possibly cause misfiring and/or deployment issues.A definitive root cause cannot be determined at this point from the details provided.Three needles were received and only one pds top hat was received for one device and the top hat was missing for the other two devices.Moreover, it was observed that top hat was received unloaded off the needle.There are shifting/ bunching of the silicon tubing part of all three needles.The distal end of the silicon tubing of one of the needles was severely damaged, indicating hitting a sharp/hard instrument during use.The deployment failure can be confirmed and may be attributed to mishandling of the devices.Other than this possibility we cannot discern a root cause for this failure.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 of any kind for this lot of devices that were released to distribution.At this point in time, 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.

Event Description

It broke when performing the shot and got away with the adjusting device.The surgeon don't use any product to resolve this problem.He closed without suturing.Additional information from the affiliate did all three anchors break in this procedure? yes was the insertion off axis? no.Did the patient have hard bone? no.Please explain what the surgeon did to complete the procedure.The form states he closed with suturing, please explain.The doctor closed without suturing.Pending doctor explanation.Did this issue extend the procedure time greater than 30 minutes? yes.Associated medwatched 1221934-2015-00655, 1221934-2015-00656.

• Brand Name: RAPIDLOC (PLA/PDS) 2/0 PANACRYL 12° CURVE NEEDLE
• Type of Device: MENISCAL IMPLANTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: bahaa nashed ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4586735
• MDR Text Key: 5448963
• Report Number: 1221934-2015-00654
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: K023388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: 228311
• Device Lot Number: 3790056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/11/2015
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2015
• Date Manufacturer Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2014
• 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