MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRO QA+ #4/0 ETH C-1; SCREW, FIXATION, BONE

Catalog Number	212866
Medical Device Problem Codes	Device Reprocessing Problem (1091); Material Fragmentation (1261); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the sales rep that prior to a finger surgery on (b)(6) 2023 the micro qa+ #4/0 eth c-1 device was found bent at opening.During an in-house engineering evaluation, it was determined that the device inserter tip was broken and there was foreign matter on in the anchor.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
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: e3: reporter is a j&j sales representative.H4: the device manufacture date is unknown.Udi: (b)(4).Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of the device received.The device was received with its packaging opened.It was evaluated.When performing the visual inspection, it was observed that the device handle, suture, shaft, inserter, sleeve and anchor do not show structural anomalies.The anchor was not attached to the inserter tip, due to the inserter tip was broken.The broken piece was not returned.Foreign matter, presumably biological was observed in the anchor.The device was sent to the qa analytical laboratory to identify the matter found in the anchor.Overall, infrared spectroscopy results revealed that the foreign material is mainly a biological based material according to characteristic absorption bands.However, source of origin remains unknown.A manufacturing record evaluation was performed for the finished device lot number and no non-conformance's were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.The manufacturer performed an investigation with the following results: a training verification has been performed at the moment in the production where the issue could have occurred.Every employee has completed the training for the processes.The batches have been assembled by operators trained and certified on the process validated in production.It is confirmed that the manufacturing process was performed in accordance with the validated processes.The root cause is not related to manufacturing since the anchor was not found bent and according with the ft-ir findings the out of the box failure cannot be sustained, therefore, this complaint was not confirmed and a possible root cause for the broken inserter tip can be attributed to procedural variables, such handling of the device or product interaction during procedure; bending force could have been applied to the inserter and consequently cause the inserter tip breakage.As per the instructions for use, do not twist or apply bending force to the inserter.Doing so may damage the anchor, suture, or inserter tip.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.

• Brand Name: MICRO QA+ #4/0 ETH C-1
• 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: 18010454
• Report Number: 1221934-2023-03888
• Device Sequence Number: 7276779
• Product Code: HWC
• UDI-Device Identifier: 10886705002535
• UDI-Public: 10886705002535
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2023

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: 212866
• Device Lot Number: 9L69808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown