MAUDE Adverse Event Report: DEPUY MITEK LLC US REUSE PATIENT SET FMS 24PK; ARTHROSCOPE

Catalog Number	284649
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the sales rep that a human hair was found inside the reuse patient set fms 24pk sterile packaging prior to being opened.There was no patient involvement.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: e3: reporter is a j&j sales representative.H4: the device manufacture date is unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
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.Device was used for treatment, not diagnosis.H11 additional narrative: 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.
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.Device was used for treatment, not diagnosis.H11 additional narrative: investigation summary - the product was returned to j&j medtech orthopaedics for evaluation.Then conducted visual inspection of the 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 found a hair inside the sealed tray.The device does not show structural anomalies.The manufacturer performed an investigation with the following results: the tube-set is manufactured in harmac's tijuana, mexico facility in an iso class 8 certified clean room facility.Harmac has very strict and detailed procedures to eliminate hair contamination in product.All people entering our cleanrooms must wear a hair net an beard cover (if they have a beard).Smocks with hoods are also worn by everyone.Harmac's standard operating procedure (sop) for environmentally controlled areas details the cleanroom requirements.Harmac sop includes photos of this process.Harmac sop contains a list of items employees must use, and in the order they must be used to enter the cleanroom.This includes entering and exiting the cleanroom.Each work station is cleaned three time per shift.A harmac employee's hair may not have been completely contained and fell into the product tray.It is also possible the tray was received form the vendor with the hair present in it went undetected during production.A quality alert was issued to the production floor and awareness training was provided.The overall complaint was confirmed as the observed condition of the reuse patient set fms 24pk would have contributed to the complained device issue.Based on the investigation findings, the potential root cause can be traced to manufacturing.A product issue was identified during the investigation of the sample received.This product issue will be addressed through j&j medtech orthopaedics quality system.Device history review - a manufacturing record evaluation was performed for the finished device number, and no non-conformances related to the reported complaint condition were identified.

• Brand Name: REUSE PATIENT SET FMS 24PK
• Common Device Name: ARTHROSCOPE
• 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: 20162560
• Report Number: 1221934-2024-03118
• Device Sequence Number: 17970310
• Product Code: HRX
• UDI-Device Identifier: 10886705023233
• UDI-Public: (01)10886705023233(10)3010589(17)260227
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K951843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• 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: 02/27/2026
• Device Catalogue Number: 284649
• Device Lot Number: 3010589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 09/20/2024; 12/12/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 09/20/2024; 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown