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); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2023
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.H10 additional narrative: h4: the device manufacture date is unknown.(b)(4) investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of the device received.The device was evaluated.Visual inspection revealed that the device was received without its original packaging, the anchor was found detached from the inserter, the anchor does not show structural anomalies.The anchor sleeve was found retracted to the handle in its full open position which indicates that the anchor was released.The handle, suture and shaft were found in a normal shape as well as the paper suture.The suture shows a section slightly impregned with foreign matter, presumably biological.The needles were not returned, a manufacturing record evaluation was performed for the finished device 135l474 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Based on the visual inspection result, this complaint cannot be confirmed.The customer reported a damaged unused device, however the device was received in used condition.The possible root cause for the condition in which the device was received can be attributed to procedural variables, such handling of the device or product interaction during procedure; the anchor sleeve was unintentionally retracted and consequently the anchor was released, however, this cannot be conclusively determined.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.There was no non conformance regarding this lot.
Event or Problem Description
It was reported by the sales rep that during an unspecified surgical procedure, the micro qa+ #3/0 eth v-4 device anchor in question was already off the inserter when the package of the anchor was opened.During an in-house engineering evaluation, it was determined that the device had foreign substance.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• 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 (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18857378
• Report Number: 1221934-2024-00785
• Device Sequence Number: 3338068
• Product Code: HWC
• UDI-Device Identifier: 10886705002528
• UDI-Public: 10886705002528
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

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: 135L474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 03/07/2024
• 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