MAUDE Adverse Event Report: DEPUY MITEK MICRO QA+ #3/0 OC V4 W/BIT; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 212843

Device Problem Detachment Of Device Component (1104)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

Product complaint #
=
> (b)(4).Device was used for treatment, not diagnosis.Udi: (b)(4).The expiration date is currently not available.

Event Description

It was reported that during a mlp joint reconstruction procedure, opened the sterile implant and the anchor was not fully seated on the handle.Surgeon went to insert the anchor and was unable to do so as the anchor slipped off.Theatre staff tried to re-insert the anchor onto the tip, however they were unable to do so.New anchor was opened and used.5 minute delay to procedure.No ae to patient.Rep not present at the time of the incident.

Manufacturer Narrative

(b)(4).Device was used for treatment, not diagnosis.The complaint device was discarded and not available for evaluation.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.A dhr review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.At this point in time, no corrective action is required and no further action is warranted.However, depuy 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: MICRO QA+ #3/0 OC V4 W/BIT
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS SARL; chemin-blanc 38; le locle 2400 ; CH 2400
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7139981
• MDR Text Key: 96056030
• Report Number: 1221934-2017-50095
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K080352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 212843
• Device Lot Number: L529045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2018
• Date Device Manufactured: 09/21/2017
• 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
• Patient Age: 14 YR