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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK OMNISPAN MENISCAL APPLIER; ORTHOPAEDIC CERCLAGE APPLIER

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DEPUY MITEK OMNISPAN MENISCAL APPLIER; ORTHOPAEDIC CERCLAGE APPLIER Back to Search Results
Catalog Number 228143
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/25/2015
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate evaluation statement: the complaint device is not being returned, therefore is unavailable for a physical evaluation.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 mitek complaints system revealed a similar complaint for this lot 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.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.(b)(4).This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
 
Event Description
This is report 2 of 2 for the same event.It was reported by the hospital that during meniscal repair, it was observed that the second implant would not fire when it was intended to.According to the report, the event occurred when the surgeon went into the knee joint.It was reported that the implant was applied to the deployment gun and the surgeon was able to fire the first implant.The surgeon then pulled the first implant out and had the nurse open a new gun and needle.He repeated the process and it worked perfect.It was reported that it was like the needle was stuck on the first implant opened.It was not reported if there were any delays in the surgical procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
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Brand Name
OMNISPAN MENISCAL APPLIER
Type of Device
ORTHOPAEDIC CERCLAGE APPLIER
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
jennifer lawrence
325 paramount drive
raynham, MA 02767
5088808100
MDR Report Key7748140
MDR Text Key116091937
Report Number1221934-2018-53223
Device Sequence Number1
Product Code GEF
UDI-Device Identifier10886705010059
UDI-Public10886705010059
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial
Report Date 02/25/2015
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 Date05/01/2017
Device Catalogue Number228143
Device Lot Number3792664
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/25/2015
Initial Date FDA Received08/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/25/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
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