MAUDE Adverse Event Report: DEPUY MITEK LLC US MENISCAL R/S APPLIER *EA; ORTHOPAEDIC CERCLAGE APPLIER

Catalog Number 228000

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2016

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.The complaint devices are not being returned, therefore unavailable for physical evaluations.A review into the depuy synthes mitek complaints system revealed no other complaints for these lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.However, depuy synthes mitek will continue to track any related complaints within these devices' families as a means of monitoring the extent with which this complaint is observed in the field.No nonconformances were identified for this product code 228000 - lot # 3820315 combination.This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.(b)(4).

Event Description

It was reported that the meniscal applier with the rapidloc 2/0 paracryl 27 degree needle handle broke during a knee scope procedure.There was no debris left in the patient and where the device broke stays outside the patient.The case was completed with a back up device and another needle using the same bone hole.There were no patient consequences but there was a minute delay in the case.

• Type of Device: ORTHOPAEDIC CERCLAGE APPLIER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 8290558
• MDR Text Key: 134575683
• Report Number: 1221934-2019-56278
• Device Sequence Number: 1
• Product Code: GEF
• UDI-Device Identifier: 10886705009930
• UDI-Public: 10886705009930
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 228000
• Device Lot Number: 3820315
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1