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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US IDEAL SUTGRASPER 60 DEG *EA; SUTURE/NEEDLE PASSER, REUSABLE
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DEPUY MITEK LLC US IDEAL SUTGRASPER 60 DEG *EA; SUTURE/NEEDLE PASSER, REUSABLE Back to Search Results
Model Number 251723
Device Problem Break (1069)
Patient Problems Tissue Damage (2104); No Patient Involvement (2645); Not Applicable (3189); No Code Available (3191)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that the ideal suture grasper, when in retract mode, while trying to retrieve the sature, the loop snaps and then the suture cannot be retrieved.The doctor has used the product for many years and is highly experienced.He still would like to use it, but wants to know what is wrong with product.Surgery was completed with alternative product.There was a surgical delay of five to ten (5-10) minutes.There was no patient consequences.This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).
 
Event Description
Additional information provided by the affiliate reports that the doctor tried to find the needle tip in the uterus muscle but they could not find the broken needle tip.It was also reported that the doctor performed an x-ray in the surgical theater but it could not be seen on the x-ray.The affiliate reported there was tissue damage due to searching for the needle tip in the muscle.
 
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The device was received and evaluated.The button on the device is stuck and will not allow the grasping wire of the device to open or retract.Visual inspection under magnification does not reveal any issues on the exterior of the grasper that would cause this defect.This complaint cannot be confirmed because there is nothing that was broken (2+ pieces) on the device.It is unknown based on the information provided and the physical inspection to determine the root cause of this failure.No nonconformances were identified for this part number (251723), lot number (2l82148) combination per qlik query executed on (b)(6) 2019.Therefore, we cannot determine what caused the user to experience the reported event; 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.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.Udi: (b)(4).
 
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Type of Device
SUTURE/NEEDLE PASSER, REUSABLE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key8560979
MDR Text Key143431058
Report Number1221934-2019-56942
Device Sequence Number1
Product Code NBH
UDI-Device Identifier10886705012312
UDI-Public(01)10886705012312
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 04/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2023
Device Model Number251723
Device Catalogue Number251723
Device Lot Number2L82148
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/01/2019
Initial Date Manufacturer Received 04/02/2019
Initial Date FDA Received04/29/2019
Supplement Dates Manufacturer Received05/01/2019
06/24/2019
Supplement Dates FDA Received05/21/2019
06/24/2019
Patient Sequence Number1
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