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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US MENISCAL DEPLOYMENT GUN; ORTHOPAEDIC CERCLAGE APPLIER
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DEPUY MITEK LLC US MENISCAL DEPLOYMENT GUN; ORTHOPAEDIC CERCLAGE APPLIER Back to Search Results
Model Number 228143
Device Problem Positioning Failure (1158)
Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348); No Code Available (3191)
Event Date 11/27/2019
Event Type  Injury  
Manufacturer Narrative
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).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
 
Event Description
This is report 4 of 5 for the same event.It was reported by the affiliate in (b)(6) that during a meniscal repair, the silicone tube of the omnispan needle has gone off through pressing the trigger of the meniscal deployment gun three times.According to the report, it was very difficult getting the silicone tube out of the joint.There was no delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
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.Additional information: subsequent follow-up with the customer, additional information was received.It was reported that the event date was (b)(6) 2019.Subsequent follow-up with the customer, additional information was received.It was reported that there was a surgical delay of approximately 10-15 minutes.It was reported that another omnispan gun and needles were readily available for use to complete the surgery.It was reported that the broken needle generated fragments in the patient.It was reported that an x-ray was performed to pull the fragments of the broken needle out of the patient's joint.It was reported that the fragments were successfully removed from the patient.Based on the additional information that a medical intervention, in this case an x-ray, was performed to remove the broken fragments of the needle inside the patient, it was determined that the reported malfunction would likely to cause or contribute to serious injury or death if it were to recur.Therefore, this complaint has been upgraded to a serious injury.If additional information should become available, a supplemental medwatch will be submitted accordingly.Patient code: 3191 (no code available) was used to capture surgical intervention.
 
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.H10 additional narrative: correction: subsequent follow-up with the customer, it was reported that there was only one meniscal deployment gun (228143) device that was broken instead of five.Therefore, this report was created in error and its initial report is being retracted.
 
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Brand Name
MENISCAL DEPLOYMENT GUN
Type of Device
ORTHOPAEDIC CERCLAGE APPLIER
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key9480760
MDR Text Key208716747
Report Number1221934-2019-59995
Device Sequence Number1
Product Code GEF
UDI-Device Identifier10886705010059
UDI-Public10886705010059
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 11/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2021
Device Model Number228143
Device Catalogue Number228143
Device Lot Number4L16539
Was Device Available for Evaluation? No
Date Manufacturer Received01/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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