MAUDE Adverse Event Report: DEPUY MITEK LLC US OMNICUT 4.2 (USED W/ MICRO HANDPIECE); ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Model Number 283345

Device Problems Device Damaged Prior to Use (2284); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2023

Event Type  malfunction  

Event Description

Part detached and water drops in package.It was reported by the distributor in china that during incoming inspection, it was observed that there were water drops inside the unopened packaging of the omnicut 4.2 (used w/ micro handpiece) device.It was further reported that the plastic ring was detached.There was no procedure nor patient involvement reported.No additional information was provided.

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed asappropriate.Investigation summary:both photos and the complaint device were received and evaluated.Four photos were returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photos.Visual analysis of the photos revealed that the device is in its packaging, it was noted that the ring is detached, also, it was noted in the photos that liquid drops are inside the packaging.The product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.The complaint device was received and evaluated; the device was received new with its original sealed primary packaging.Upon visual inspection it was observed that the device ring was detached.Also, some fluid drops were noted inside packaging.A manufacturing record evaluation was performed for the finished device a2208019 number, and no non-conformances related to the reported complaint condition were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.The device was sent to the qa analytical laboratory for its chemical composition, infrared analysis was carried out in accordance with laboratory test method ltm-0002 rev.E "identification of materials by infrared spectroscopy" and the use of ft-ir instrument was performed in accordance with qap-0706 rev.D.Overall, ir data reveals that unknown material showed the absorption bands for fluoropolymer-based material.The manufacturer performed an investigation with the photos provided by the customer with the following results: based on visual evaluation, the ring was confirmed to be detached.The defect described as ¿water drops¿ does not appear to be water, but possibly grease that is used as part of the assembly of the devices.According with the ft-ir result, the manufacturer confirmed that is the grease used in the manufacturing process of the device.The issue was confirmed for ring identifier detachment.Questionable determination on grease within packaging.This is not likely from manufacturing, grease in packaging is usually isolated and infrequent, not recurring regularly.The device was manufactured in august 2022 the devices regularly underwent 100% inspection.Currently under 200% inspection due to a temporary deviation in place in which associates perform a 100% secondary inspection prior to quality¿s 100% inspection.This inspection is based off of a checklist that specifically calls verification for the presence of a ring identifier (and per training, this is expected to be properly assembled on the device and the operator is to ensure this when verifying ring identifier presence) also an inspection related to grease on outer tubes, hubs and packaging among others.However, the deviation was not in effect when the device was manufactured, the lot still would have undergone 100% inspection from quality.Control documents for quality inspection; ims 246143 rev j and td23-003 mitek inspection checklist.Root cause for ring detachment and grease within the inside of the tray could be potentially related to in-transit turbulence/movement.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: OMNICUT 4.2 (USED W/ MICRO HANDPIECE)
• Type of Device: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• 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: 16763505
• MDR Text Key: 313527800
• Report Number: 1221934-2023-01684
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705022472
• UDI-Public: 10886705022472
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K041824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283345
• Device Catalogue Number: 283345
• Device Lot Number: A2208019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1