MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CRVD AGG BLADE 4.2MM 5PK; ARTHROSCOPE

Catalog Number	283412
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This is report 2 of 4 for (b)(4).It was reported that preoperatively to an unspecified surgical procedure, it was observed that the description on the box of an unknown cutting instrument device did not match the content.According to the report, the customer ordered curved shaver blades.It said on the box that the box contained five curved shaver blades but only one was curved and four were not curved.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown but was noted to have occurred in december 2024.All available information has been disclosed.
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.Device was used for treatment, not diagnosis.H11 additional narrative: d1, d4, g4 (510k), h4: this report is for an unknown cutting instrument.Part and lot number are unknown.Without the specific part number; the expiration date, udi number, 510-k number and device manufacture date are unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
This is report 2 of 4 for (b)(4).It was reported that preoperatively to an unspecified surgical procedure, it was observed that the contents of the box did not match the description of the crvd agg blade 4.2mm 5pk device.According to the report, only one out of the five blades was curved.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown but was noted to have occurred in (b)(6) 2024.All available information has been disclosed.
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.Device was used for treatment, not diagnosis.H11 additional narrative: b5, d1, d4, g4, h4: brand name, common device name, procode, catalog, lot number, udi, expiration date, 510(k), device manufacture date corrected.
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.Device was used for treatment, not diagnosis.H11 additional narrative: d9, 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.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.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the device inside the sealed blister and missing the curved part at the shaft.No other anomalies were noted.The manufacturer performed an evaluation with the following results: final manufacturing step was not completed; the blade should be curved per manufacturing step prior to being packaged.Per the internal operating procedures, 100% of the products are to be inspected following the bending operation.Therefore, it has been concluded that only an operator mistake can lead to this failure.It has been confirmed that all operators were trained to the internal operating procedures.The assignable root cause has been linked to human error and as the production site is no longer operating, awareness cannot be performed in production.The overall complaint was confirmed as the observed condition of the crvd full radius bld 4.2mm 5pk would have contributed to the complained device issue.Based on the information currently available, a product issue was identified during the investigation of the sample received and attributed to manufacturing.This product issue will be addressed through j&j medtech orthopaedics quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: CRVD AGG BLADE 4.2MM 5PK
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 21252911
• Report Number: 1221934-2025-00389
• Device Sequence Number: 8243715
• Product Code: HRX
• UDI-Device Identifier: 10886705025923
• UDI-Public: 10886705025923
• 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,Followup
• Report Date (Section B): 01/28/2025

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: 283412
• Device Lot Number: 268L592
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: 01/28/2025; 02/25/2025; 03/13/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 01/28/2025; 02/26/2025; 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• 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