MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - CUTTING INSTRUMENT; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Catalog Number UNK - CUTTING INSTRUMENT

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Type  malfunction  

Event Description

It was reported by the sales rep in (b)(6) that the cutters of the fms vue equipment have an excess of lubricant inside the blade.According to the report, there was a white patina on the housing of the tip of the blade.There was no procedure nor patient involvement reported.No additional information was provided.

Manufacturer Narrative

This report is for an unknown cutting instrument.Part and lot number are unknown.Without the specific part number; the udi number, 510-k number and manufacturing site name are unknown.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: investigation summary: according to the information received, it was reported that the cutters of the fms vue equipment have an excess of lubricant inside the blade.The photos show that there is a white patina on the housing of the tip of the blade.Within the same package, all the blades had the same defect and were not used on the patient.The complaint device is not being returned, therefore unavailable for a physical evaluation.However, photos were provided.Upon visual inspection of the photo, a layer of lubricant is observed at the tip of the inner, but it was not possible to see all the condition of the lubricant.The photo do not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to determine the root cause.A manufacturing investigation was performed; as a result, there are controls in place related to the grease application.The outer tip grease, and in the line release the quality inspector take one piece during the shift or lot and weight the grease of the inner/outer based on the quality work instruction and the results are documented.Also, they perform a visual inspection during the process, to review the final condition of the lubricant in the blade.For the final inspection and cleaning process, one step of the inspection is related to the excess grease at the tip; this control is important to avoid quality rejection.Based on the photo and the information provided by the manufacturer, this complaint cannot be confirmed.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.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: UNK - CUTTING INSTRUMENT
• Type of Device: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12772915
• MDR Text Key: 280950934
• Report Number: 1221934-2021-03278
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

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 Catalogue Number: UNK - CUTTING INSTRUMENT
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 12/09/2021
• Supplement Dates FDA Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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