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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 Problems Separation Failure (2547); Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/30/2018
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.(b)(4).
 
Event Description
During the lca reconstruction surgery, the single use trocar tip blocked and welded on the single use sleeve.The issue was solved using another kit 210133.No patient consequence.Additional information from affiliate: type of procedure: acl reconstruction.No delay reported.
 
Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Investigation summary: the complaint device was received and evaluated.The label was returned with the device.The part number and lot number were confirmed.Visually, the outer surface of the sleeve and trocar had striations and nicks, indicating there was a loose fit within the guide frame during use.The trocar interlocking pin is still intact.The sleeve and trocar were jammed together and could not separate, indicating a ¿cold weld¿ occurred during drilling, thus confirming this complaint.Upon further observation the sleeve was discovered not interlocked with the trocar pin, indicating a poor assembly prior to use, which could¿ve created a loose fit resulting to the failure reported.Furthermore, another possible root cause for this type of failure could be that the guide frame was out of alignment with the sleeve which could cause the frame to bind up with the sleeve/trocar resulting in cold welding of the two parts.This failure can be attributed to user technique.The dhr review indicated that this batch of devices were processed without incident, therefore, there is no evidence of manufacturing anomalies on the records reviewed.Furthermore, a review into the depuy mitek complaints system revealed one dissimilar complaint for this lot of devices that were released to distribution.And at this 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.Udi: (b)(4).
 
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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
MDR Report Key7613071
MDR Text Key111440679
Report Number1221934-2018-52029
Device Sequence Number1
Product Code HTY
UDI-Device Identifier10886705000890
UDI-Public10886705000890
Combination Product (y/n)N
PMA/PMN Number
K974341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/06/2018
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 Date10/31/2020
Device Catalogue Number210133
Device Lot NumberL642025
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2018
Initial Date Manufacturer Received 06/06/2018
Initial Date FDA Received06/19/2018
Supplement Dates Manufacturer Received06/06/2018
Supplement Dates FDA Received07/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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