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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 Mechanical Jam (2983)
Patient Problem Not Applicable (3189)
Event Date 05/23/2017
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).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.The reported failure could be confirmed from the visible striation marks on the trocar where it had cold welded with the sleeve.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.Therefore, this type of failure has been attributed to user technique issue.A review into the mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.A non-conformance search was performed to identify an non-conformance associated with this part-lot combination.No non-conformances were identified for this part-lot number (part: 210133, lot number: l188273) combination.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.(b)(4).This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
 
Event Description
The affiliate reported via email during procedure the pin stayed stuck in the sleeve during a tendon repair.No information regarding patient consequence reported to date.Additional information received via email from the affiliate on 6-7-17: it is unknown if the failure was the sleeve and trocar welded together.The procedure was completed with another rigidfix kit.The delay was less than 30 minutes.
 
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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
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key8399460
MDR Text Key138106946
Report Number1221934-2019-56577
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 Health Care Professional
Type of Report Initial
Report Date 06/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2019
Device Catalogue Number210133
Device Lot NumberL188273
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/02/2017
Initial Date FDA Received03/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2016
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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