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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 No Consequences Or Impact To Patient (2199)
Event Date 05/05/2016
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.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 and 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 mitek complaints system revealed 1 similar complaint for this lot of devices that were released to distribution.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)(6) 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 by the sales rep that during an acl repair that the customer's trocar and sleeve of their rigidfix soft tissue 3.3mm cross pin kit became cold welded.The surgeon completed the procedure with another like kit with no patient consequences/ there was a 5 minute delay reported.
 
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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
325 paramount drive
raynham MA 02767
Manufacturer Contact
jennifer lawrence 
325 paramount drive
raynham, MA 02767
5088808100
MDR Report Key7796291
MDR Text Key117577111
Report Number1221934-2018-51560
Device Sequence Number1
Product Code HTY
UDI-Device Identifier10886705000890
UDI-Public10886705000890
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K974341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/05/2016
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 Catalogue Number210133
Device Lot Number3870367
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/05/2016
Initial Date FDA Received08/19/2018
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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