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

Catalog Number 210133

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2018

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.(b)(4).

Event Description

It was reported that the plug is welded.The procedure was lca.

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.Device was used for treatment, not diagnosis.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 inspected.The complaint can be confirmed.It was observed that the trocar and sleeve have become welded together.Visual inspection revealed numerous striations along the trocar and the sleeve shaft.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.The root cause for this failure can be attributed to user technique.A non-conformance was identified for this lot number however the complaint condition is unrelated to the non-conformance.At this point, 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).

Event Description

Additional information received on 06november2018: there was no permanent damage.There was no need for an inpatient stay or long hospitalization.No re-operation was needed.There was no serious damage.

• 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: 7742508
• MDR Text Key: 116066098
• Report Number: 1221934-2018-54299
• 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: 07/05/2018

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: 11/30/2020
• Device Catalogue Number: 210133
• Device Lot Number: L689992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 11/06/2018
• Supplement Dates FDA Received: 11/06/2018
• Patient Sequence Number: 1