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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
Catalog Number 251723
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/05/2019
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
 
Event Description
It was reported by the affiliate that during an arthroscopic rotator cuff repair the ideal sutgrasper 60 deg *ea caught two sutures at the same time, since the sutures didn¿t slide properly the wire broke.As per the affiliate this was the first used of the device.No patient consequence and no surgical delay was reported.No additional information was provided.The affiliate later reported the case completed but could not provide additional details.The affiliate also reported the alleged malfunction occurred when the tip of the wire was stretched and all fragments were removed from the patient.
 
Manufacturer Narrative
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.Device was used for treatment, not diagnosis.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
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.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.H10 additional narrative: investigation summary: the complaint device was received and inspected.Visual observation indicates the distal end of the wire was broken, confirming this complaint.The second half of the wire was not returned.Based on the information provided it is suggested that the two sutures were caught in the suture grasper at the same time and due to inappropriately sliding of the suture(s) caused the wire to break.The potential cause for this issue is not related to manufacturing, therefore a manufacturing record evaluation is not required.At this point in time, no corrective action is required, and no further action is warranted.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 potential cause for this issue is not related to manufacturing, therefore a manufacturing record evaluation is not required.
 
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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 Key9402804
MDR Text Key208183793
Report Number1221934-2019-59813
Device Sequence Number1
Product Code NBH
UDI-Device Identifier10886705012312
UDI-Public10886705012312
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup,Followup
Report Date 11/07/2019
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 Date05/31/2024
Device Catalogue Number251723
Device Lot Number4L87007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2019
Initial Date Manufacturer Received 11/07/2019
Initial Date FDA Received12/03/2019
Supplement Dates Manufacturer Received12/04/2019
01/08/2020
Supplement Dates FDA Received12/23/2019
01/08/2020
Patient Sequence Number1
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