MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRO QA+ #3/0 OC V4; SCREW, FIXATION, BONE

Catalog Number	212843
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.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.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
It was reported that during an unspecified surgical procedure the micro qa+ #3/0 oc v4 device, during implantation, the needles were not attached to the anchor wires; the needles were present in the ancillary kit.Another device was used.There were no patient consequences.It was not reported if there were any delays in the surgical procedure.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.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: the actual device was returned for evaluation.However, the device was misrouted or lost after receipt.Investigation could not be completed at this time.This issue has been escalated to corrective action to document and further investigate the issue.Device history lot: there was no non-conformances regarding this lot.

• Brand Name: MICRO QA+ #3/0 OC V4
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 20598505
• Report Number: 1221934-2024-03931
• Device Sequence Number: 6550856
• Product Code: HWC
• UDI-Device Identifier: 10886705002375
• UDI-Public: (01)10886705002375(10)268L498(17)270131
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K080352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 212843
• Device Lot Number: 268L498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown