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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US OMNISPAN MENISCAL REPAIR 27DEG; SOFT-TISSUE ANCHOR, BIOABSORBABLE
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DEPUY MITEK LLC US OMNISPAN MENISCAL REPAIR 27DEG; SOFT-TISSUE ANCHOR, BIOABSORBABLE Back to Search Results
Catalog Number 228142
Device Problem Premature Activation (1484)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/09/2019
Event Type  malfunction  
Manufacturer Narrative
Product complaint #
=
> (b)(4).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.Udi: (b)(4).
 
Event Description
It was reported by affiliate via phone that during a meniscus repair, two omnispan meniscal repair system/27 degree, presented defect.For the lot 4l46930, after 1st firing, two plated were deployed at the same time.For the lot 4l88417, after 1st firing, the device could not fire again.Another device was used to complete the surgery.No patient consequences or surgical delay reported.Please refer to the attached photos of the defect product.No additional information could be provided.
 
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: d10, h3, h6: 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.Investigation summary : the complaint device was received and evaluated.Upon inspection, it was found that the device was incomplete as the meniscal deployment gun was not returned.Without the gun, a physical evaluation cannot be conducted.However, only the needle and both implants with the suture attached were returned.A visual inspection was performed to determine if there were any gross visual defects that may have contributed to the reported complaint condition.No anomalies were observed.No silicone tube was missing.Implants were not on the needle, indicating it had been fired, therefore this complaint is not confirmed.Based on the information, at this time, the failure cannot be confirmed or a root cause cannot be determined.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.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.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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Brand Name
OMNISPAN MENISCAL REPAIR 27DEG
Type of Device
SOFT-TISSUE ANCHOR, BIOABSORBABLE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key9522108
MDR Text Key205144795
Report Number1221934-2019-60163
Device Sequence Number1
Product Code MAI
UDI-Device Identifier10886705010042
UDI-Public10886705010042
Combination Product (y/n)N
PMA/PMN Number
K150209
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 12/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2022
Device Catalogue Number228142
Device Lot Number4L46930
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2020
Date Manufacturer Received01/10/2020
Patient Sequence Number1
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