MAUDE Adverse Event Report: DEPUY MITEK LLC US OMNISPAN MENISCAL APPLIER; ORTHOPAEDIC CERCLAGE APPLIER

Catalog Number 228143

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2013

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.Investigation summary.Evaluation statement: the complaint device was discarded at the facility and hence not available for a physical evaluation.From the report provided, it seems that the issue was with omnispan applier and without the device, we cannot confirm this complaint.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 no other complaints for this lot of 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.Device history lot: the batch review 3653489 showed that the devices were conformed to in process and finished goods specifications when released to stock the 12 nov.2012.Expiration date: 2015-10 (according to retained labels).No nonconformance was opened.The (b)(4) was opened relating to deals with a maintenance issue linked to the vacuum dry oven, with no link with this complaint.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

Our affiliate reported the physician tried to deliver the implant with the gun but wasn¿t successful.He changed the deployment gun and tried a second time (again unsuccessfully).Deployment worked at third attempt with the third deployment gun.Afterwards, the physician dissembled the devices.The guns were discarded, remaining parts (needles etc.) are being returned.Procedure was prolonged appr.5 ¿ 10 minutes.No patient harm reported.Please see also medwatch report 1221934-2018-53474, 1221934-2018-53467 and 1221934-2018-53470.

• Brand Name: OMNISPAN MENISCAL APPLIER
• Type of Device: ORTHOPAEDIC CERCLAGE APPLIER
• 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: 7683011
• MDR Text Key: 114039905
• Report Number: 1221934-2018-53475
• Device Sequence Number: 1
• Product Code: GEF
• UDI-Device Identifier: 10886705010059
• UDI-Public: 10886705010059
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/26/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Catalogue Number: 228143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2012
• 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