MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CRVD MULTI BLADE 4.2MM 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Model Number 283432

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 11/23/2021

Event Type  malfunction  

Event Description

It was reported by that the crvd multi blade 4.2mm blade device had a black foreign material.There was no procedure nor patient involvement reported.No additional information was provided.

Manufacturer 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.

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.H10 additional narrative: d9, h3, 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.

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.H10 additional narrative: investigation summary
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> the product was returned for evaluation.Mitek then conducted visual inspection of device received.Upon visual inspection, the device was received in its original packaging and unopened.It was identified a black spot inside the package.This complaint can be confirmed.A manufacturing record evaluation was performed for the finished device lot number: 8l26115, and no non-conformances related to the reported complaint condition were identified.A manufacture investigation was performed to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Based on the above, it is confirmed that the manufacturing process has been performed according to the validated processes.The root cause is not manufacturing related.The manufacturer demonstrated the controls in place during the inspection of the packaging to avoid this type of reported issue.Likewise, an inspection of the product and the process was made, the results show that this batch of product was processed without any incident; the results of production controls (100%) and in-process controls (9 samples) are all compliant.A ft-ir (fourier transform infrared spectroscopy) analysis was performed.The purpose of this analysis is to identify chemical composition.Overall, ft-ir results obtained that screw is primarily composed of polyester-based material, see attachment "pc-001031531_1813-30_1"; as a result, the material is composed by polysulfone-base; the source of origin remains unknown.According to the manufacturer information, the visual inspection of stains and fibers should be carried out according to the criteria mentioned below, and as mentioned in our procedure wi-ft0119, measurement of spot size should be performed using tappi chart t213, t437.Particle and fiber size measurement: particles and/or loose fibers inside the blister or pouch > acceptance criteria: no particles larger than 0.8 mm2 , no fibers larger than 0.8 mm in length, 5 particles maximum smaller than 0.8mm2.The measurement of the foreign material found inside the packaging is approximately 3 mm.The particle found during the complaint is meeting the internal specification of acceptance, then there is no corrective action required.Further, a review into the mitek complaints system revealed one dissimilar complaint reported for this lot of 300 devices that were released to distribution.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: CRVD MULTI BLADE 4.2MM 5PK
• Type of Device: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• 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: 12953170
• MDR Text Key: 281858858
• Report Number: 1221934-2021-03626
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705025961
• UDI-Public: 10886705025961
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2021

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 Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 283432
• Device Catalogue Number: 283432
• Device Lot Number: 8L26115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 12/22/2021; 05/27/2022
• Supplement Dates FDA Received: 12/23/2021; 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2021
• 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