MAUDE Adverse Event Report: DEPUY MITEK LLC US OMNISPAN MENISCAL REPAIR 12DEG; SOFT-TISSUE MENISCAL REPAIR ANCHOR, BIOABSORBABLE

Model Number 228141

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device was used for treatment, not diagnosis.

Event Description

It was reported by the affiliate that during the procedure, the anchor got detached from the deployment gun.Use of a 2nd anchor.No stop of the procedure nor change of technique.20 minutes of delay in the procedure.No patient consequences.

Manufacturer Narrative

Product complaint # (b)(4).Device was used for treatment, not diagnosis.

Event Description

It was reported by the affiliate that during the procedure, the anchor got detached from the deployment gun.Use of a 2nd anchor.No stop of the procedure nor change of technique.20 minutes of delay in the procedure; no patient consequences.

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.Investigation summary: the device was received and evaluated.Visual inspection under magnification revealed no anomalies on the device.The anchors are intact under the silicon tube.The needle was loaded onto an omnispan gun and locked as intended.We cannot determine what caused the user to experience the reported event; we cannot discern a root cause for the reported failure mode.This complaint cannot be confirmed.No ncrs were generated during production.Review of the device history records showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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.

• Brand Name: OMNISPAN MENISCAL REPAIR 12DEG
• Type of Device: SOFT-TISSUE MENISCAL REPAIR ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7272582
• MDR Text Key: 100171595
• Report Number: 1221934-2018-50179
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705010035
• UDI-Public: (01)10886705010035(10)L604139(17)200930
• Combination Product (y/n): N
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 228141
• Device Catalogue Number: 228141
• Device Lot Number: L604139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Date Manufacturer Received: 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1