MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.0MM MULTIBLADE PLUS 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Model Number	283439
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer in (b)(6) that during a knee arthroscopy surgery on an unknown date, it was observed that a small black ¿thing¿ was in the plastic part of the packing of the blade device.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).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.
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 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.Investigation summary: the complaint device was received for evaluation.The device is inside in a completely sealed blister, there is a 3mm semi-circle shaped black particle inside the blister, the blister was unsealed to get the black particle and verify the material.The object was sent to the qa analytical laboratory for its chemical identification.Infrared analysis was carried out in accordance with laboratory test method ¿identification of materials by infrared spectroscopy¿ and the use of ft-ir instrument was performed.Ir data revealed that unknown material is composed by polysulfone-base material.Presumably inner/outer assembly components from multiblade device can be pinpointed as the potential source of origin.A manufacturing record evaluation was performed for the finished device m2108003, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection, this complaint can be confirmed.The fibers are generated during the induction welding process of the (black ultem) hubs to the (s.S.) tubes.The induction welding process generates flash that can become loose from the hub and then turn into the loose black ultem fiber.The supplier should be inspecting and removing the flash / fibers post the welding operation.An nc was opened to track this failure with the supplier ((b)(4)).A deeper investigation will be performed under this action.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: 4.0MM MULTIBLADE PLUS 5PK
• Common Device Name: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• 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: 14211088
• Report Number: 1221934-2022-01220
• Device Sequence Number: 19942322
• Product Code: HRX
• UDI-Device Identifier: 10886705022038
• UDI-Public: 10886705022038
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K131191
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup

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
• Device Expiration Date: 07/31/2026
• Device Model Number: 283439
• Device Catalogue Number: 283439
• Device Lot Number: M2108003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 06/19/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown