MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRO QA+ #3/0 ETH V-4 W/BIT; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 212865

Device Problems Bent (1059); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2018

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.Investigation summary: the complaint device was received and evaluated with npd.The original packaging and labels were returned with the device.The product code and lot number information were confirmed.Visual observation reveals that the anchor is off the inserter but still intact and held in place by the suture.The anchor itself was inspected under a microscope and revealed no structural anomalies.The distal tip of the sleeve however had one of the tabs bent out, which could¿ve caused the anchor to fall off the inserter.This complaint can be confirmed.Possible root cause for the bent sleeve tab which also lead to the anchor falling off the inserter prematurely could be from excessive force made on the distal tip, or during assembly of the device.Other the possible root causes listed a specific root cause cannot be determined.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.A review of the depuy synthes mitek complaints system revealed no complaints of any type for this lot of devices that were released to distribution.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 to monitor the extent to which this complaint is observed in the field.Udi: (b)(4).

Event Description

It was reported via phone that during a wrist procedure, the anchor released from the device prematurely.The doctor used another like device to complete the procedure.There were no patient consequences or delays.The device is coming back.

• Brand Name: MICRO QA+ #3/0 ETH V-4 W/BIT
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 7496243
• MDR Text Key: 107743981
• Report Number: 1221934-2018-50592
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886705002528
• UDI-Public: 10886705002528
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 212865
• Device Lot Number: L512899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1