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

Model Number 212865

Device Problems Break (1069); Component Missing (2306); Device Contamination with Chemical or Other Material (2944)

Patient Problem Not Applicable (3189)

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.Investigation summary: according to the information provided, it was reported that the micro qa+ #3/0 eth v-4 was opened from the sterile box and has given from the nurse to the operator / doctor.The anchor was in a various position on the seating instrument.The complaint device was received and evaluated.Visual observations reveals that the micro anchor and the cover were not received.In addition, the tip of sleeve inserter was found broken.Besides, the device had sings of biological residues and two mini drills were received in the package.The complaint cannot be confirmed.The possible root cause for the reported failure can be attributed to user mishandling of the device.However, this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no non-conformances related to the reported complaint condition were identified 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.Udi: (b)(4).

Event Description

It was reported by affiliate via complaint submission tool that before procedure the micro qa+ #3/0 eth v-4 was opened from the sterile box and has given from the nurse to the operateur / doctor.The anchor was in a varios position on the seating instrument.A new anchor was opened.The same problem.Implantation was done.No patient consequences or surgical delay reported.The device is available to be returned for evaluation additional information received from affiliate reported a 20 minute surgical delay to the procedure to the event.The affiliate also reported the procedure was completed with another suture anchor which was readily available.It was reported the current status of the patient is unknown and surgical intervention is not required.

• Brand Name: MICRO QA+ #3/0 ETH V-4
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT MITEK; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10125516
• MDR Text Key: 198945796
• Report Number: 1221934-2020-01506
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886705002528
• UDI-Public: 10886705002528
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K024115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 212865
• Device Catalogue Number: 212865
• Device Lot Number: 4L67420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Date Manufacturer Received: 05/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1