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

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).

• 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 Key: 7613071
• MDR Text Key: 111440679
• Report Number: 1221934-2018-52029
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 10886705000890
• UDI-Public: 10886705000890
• Combination Product (y/n): N
• PMA/PMN Number: K974341
• Number of Events Reported: 1
• 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 Date: 10/31/2020
• Device Catalogue Number: 210133
• Device Lot Number: L642025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 06/06/2018
• Supplement Dates FDA Received: 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1