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

Catalog Number 212865

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).Investigation summary: the complaint device was discarded and not available for evaluation.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.A non-conformance search was performed for this part (212865), lot (l964344) combination and no non-conformances were identified.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required, and no further action is warranted.However, should any new information be provided in future, this file will be re-opened, and a thorough investigation will be performed.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.

Event Description

This is report 2 of 2 for the same event.It was reported by the sales rep in (b)(6) that during sl band refixation surgical procedure, it was observed that two micro quick anchor+ 3/0 ethibond devices were not possible to release from their mechansms.According to the reporter, the devices were not inside the patient, so no removal was necessary.It was further reported that there was no bone hole needed at the time of the event.It was not reported if there was a delay in the procedure but it was reported that spare devices were available for use to complete the procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• 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): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8170524
• MDR Text Key: 130669589
• Report Number: 1221934-2018-55691
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886705002528
• UDI-Public: 10886705002528
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 212865
• Device Lot Number: L964344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1