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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX CURVE ACL ST PLA CROSS PIN KIT; SOFT-TISSUE ANCHOR, BIOABSORBABLE

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DEPUY MITEK LLC US RIGIDFIX CURVE ACL ST PLA CROSS PIN KIT; SOFT-TISSUE ANCHOR, BIOABSORBABLE Back to Search Results
Catalog Number 213013
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/16/2013
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 no other complaints of any kind 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.Udi: (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 affiliate in (b)(6) that during anterior cruciate ligament (acl) repair, it was observed that the eyebolt of the drill got broken two times, the sheath got stuck.The surgery was finished successfully with an interference screw.It was not reported if there were any delays in a 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
RIGIDFIX CURVE ACL ST PLA CROSS PIN KIT
Type of Device
SOFT-TISSUE ANCHOR, BIOABSORBABLE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
jennifer lawrence
325 paramount drive
raynham, MA 02767
5088808100
MDR Report Key7800999
MDR Text Key117727163
Report Number1221934-2018-51518
Device Sequence Number1
Product Code HTY
UDI-Device Identifier20886705020000
UDI-Public20886705020000
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K130105
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 12/16/2013
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 Date06/01/2016
Device Catalogue Number213013
Device Lot Number3714813
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/16/2013
Initial Date FDA Received08/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/09/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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