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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEM 3.3MM S/T XPIN; SOFT-TISSUE ANCHOR, BIOABSORBABLE

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DEPUY MITEK LLC US RIGIDFIX FEM 3.3MM S/T XPIN; SOFT-TISSUE ANCHOR, BIOABSORBABLE Back to Search Results
Catalog Number 210133
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/29/2015
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 was received and evaluated.The reported failure could be confirmed from the visible mark on the trocar where it had cold welded with the sleeve.Historically, this type of failure has been attributed to user technique issue.The location of the trocar interlocking pins is superior to the mating portion of the sleeve.If the pins are not seated within these groves then the trocar is spinning within the guide sleeve causing enough heat and friction to cause the "welding" of the two parts.A batch record review has been conducted for this lot of 499 devices that were manufactured in 2014 and the results indicate that this batch of product was processed without incident related to the failure in this complaint and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed one similar complaint for this lot number for this device.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.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
It was reported that the pin of one (1) rigidfix femoral 3.3 mm s/t pin gets stuck in the mandrel.Fins of the pin were broken.Further, it was reported that during drilling of one (1) sleeve, the external fins of the interlocking trocar broke and consequently, it was impossible to remove the interlocking trocar without leaving the sleeve out of the bone.Procedure was completed with use of another like device.There were no consequences to the patient.
 
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Brand Name
RIGIDFIX FEM 3.3MM S/T XPIN
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 Key7844060
MDR Text Key119669417
Report Number1221934-2018-54397
Device Sequence Number1
Product Code HTY
UDI-Device Identifier10886705000890
UDI-Public10886705000890
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K974341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Other
Type of Report Initial
Report Date 02/20/2015
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 Date08/31/2017
Device Catalogue Number210133
Device Lot Number3794973
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2015
Initial Date Manufacturer Received 02/20/2015
Initial Date FDA Received09/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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