MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 2.7MM MINI ULTRA-AGGR PLUS 5PK; ATHROSCOPIC SHAVER SYSTEM BLADE

Model Number	283229
Medical Device Problem Code	Break (1069)
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 affiliate in (b)(6) that during an unknown arthroscopic procedure on an unknown date, it was observed that there were metal abrasions in the wrist joint while using the 2.7mm mini ultra-aggr plus 5pk device.All the fragments were removed.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
Additional Manufacturer Narrative
Additional narrative: 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.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device was returned received and evaluated.On visual inspection, the inner and outer sleeves were separated and inspected for any visual defects that may contribute to the complaint condition.The outer shaft shows friction and striation marks on the inner surface.Also, the inner blade shows friction marks near the distal part.The customer provided a photo which shows the metal particles inside the joint.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.The possible root cause for reported failure can be attributed to procedural variables, such handling of the device or product interaction during procedure; as per ifu: excessive side loading may result in blade wear and degradation.Adequate suction is recommended to reduce wear and degradation of the device.Besides, the handpiece used in this procedure was not received for evaluation, potential ways to reduce shedding is to ensure all hand pieces are properly serviced and maintained.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: 2.7MM MINI ULTRA-AGGR PLUS 5PK
• Common Device Name: ATHROSCOPIC SHAVER SYSTEM BLADE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle CH-24-00 ; SZ CH-2400 ; 6013142063
• MDR Report Key: 13637258
• Report Number: 1221934-2022-00661
• Device Sequence Number: 5201367
• Product Code: HRX
• UDI-Device Identifier: 10886705027194
• UDI-Public: 10886705027194
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: 283229
• Device Catalogue Number: 283229
• Device Lot Number: A1911008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 03/03/2022; 03/29/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 03/04/2022; 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2020
• 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