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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK 60° SUTURE GRASPER; ANCHOR INSTRUMENTS
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DEPUY MITEK 60° SUTURE GRASPER; ANCHOR INSTRUMENTS Back to Search Results
Catalog Number 251723
Device Problem Tip breakage (1638)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/05/2015
Event Type  malfunction  
Event Description
Tip broke off.Procedure was completed with same like product.Additional information from the affiliate stated - it broke in the patient and every piece was retrieved from the patient.It extended the case by 5 minutes only.
 
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.Awaiting return.
 
Manufacturer Narrative
The complaint device is not being returned, therefore unavailable for a physical evaluation.This type of failure is typically observed when excess force is exerted at an off angle while using the device.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 synthes mitek complaints system revealed no other complaints of any kind for this 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.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes 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
Tip broke off.Procedure was completed with same like product.Additional information from the affiliate stated - it broke in the patient and every piece was retrieved from the patient.It extended the case by 5 minutes only.
 
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Brand Name
60° SUTURE GRASPER
Type of Device
ANCHOR INSTRUMENTS
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 Key4535226
MDR Text Key5519856
Report Number1221934-2015-00625
Device Sequence Number1
Product Code NBH
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 02/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2019
Device Catalogue Number251723
Device Lot Number3784087
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date02/05/2015
Device Age6 MO
Event Location Hospital
Date Report to Manufacturer02/05/2015
Date Manufacturer Received02/05/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/02/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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