MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.0MM MULTIBLADE PLUS 5PK; ARTHROSCOPE

Catalog Number 283439

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 11/20/2023

Event Type  malfunction  

Event Description

Report 2 of 2 of (b)(4).It was reported by the sales rep in switzerland that during a knee surgery on (b)(6) 2023 when the surgeon was shivering the tissue in the joint with the shaver handpiece 2.0 with buttons device, a black liquid came out of the suction tubing from the shaver handpiece device.It was reported that nothing was visible in the joint, only in the shaver outflow tubing and the scrub nurse thought first it was oil from the shaver handpiece device but the liquid was not floating on the waste bin so she wasn't sure what it was exactly.There was a four minute delay in the procedure reported.There were no adverse patient consequences reported.No additional information was provided.

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 device manufacture date is unknown udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

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.The investigation has been updated to reflect the correct information: investigation summary: according to the information provided, it was reported that the surgeon was shavering the tissue in the joint as suddenly a black liquid came out of the suction tubing from the shaver handpiece.Nothing was visible in the joint, only in the shaver outflow tubing.The scrub nurse thought first it was oil from the shaver handpiece but the liquid was not floating on the waste bin.So she wasn't sure what it was exactly.The complaint device is not being returned, it was retained by the customer, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device lot number (m2308002), and no non-conformance was identified.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.Correction h4: the device manufacture date was reported as unknown on the initial report.Please note that the date of manufacture has been updated accordingly.

• Brand Name: 4.0MM MULTIBLADE PLUS 5PK
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 18275473
• MDR Text Key: 329900210
• Report Number: 1221934-2023-04425
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705022038
• UDI-Public: 10886705022038
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K131191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

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: 283439
• Device Lot Number: M2308002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2023
• 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