MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRO QA+ #3/0 ETH V-4; SCREW, FIXATION, BONE

Catalog Number	212865
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported from india that the that the micro qa+ #3/0 eth v-4 device anchor implant was opened the anchor was dislodged from the insertion tab and hence the surgeon was not able to deploy the anchor.During an in-house engineering evaluation, it was determined that the anchor is detached from the inserter tip.The transparent sleeve that holds the anchor was found completely retracted.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any 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.H10 additional narrative: d4 h4: the device expiration date and date of manufacture are unknown at this time.Udi: (b)(4).Investigation summary: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection found that the anchor is detached from the inserter tip.The transparent sleeve that holds the anchor was found completely retracted.The overall complaint was confirmed as the observed condition of the micro qa+ #3/0 eth v-4 would contribute to the complained device issue.The photo investigation revealed that micro qa+ #3/0 eth v-4 had the anchor detached from the inserter tip.The transparent sleeve that holds the anchor was found completely retracted.Based on the investigation findings, the potential cause is traced to procedural variables, such handling of the device or product interaction during procedure, the operator could have retracted the transparent plastic sleeve that holds the anchor during device opening, leading to a pre-released anchor, however, this cannot be conclusively determined.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: MICRO QA+ #3/0 ETH V-4
• 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: 18928530
• Report Number: 1221934-2024-00923
• Device Sequence Number: 14587781
• Product Code: HWC
• UDI-Device Identifier: 10886705002528
• UDI-Public: 10886705002528
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K024115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/19/2024

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: 212865
• Device Lot Number: 169L189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown