MAUDE Adverse Event Report: DEPUY MITEK LLC US BARREL BURR 4.0MM 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Catalog Number	283469
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.(b)(4).
Event or Problem Description
As per the sales rep via email, fms pump began beeping during a subacromial decompression procedure and the micro tornado handpiece with hand controls would not activate.A new handpiece was opened, and issue was resolved.Since both handpieces were opened on the sterile field, after the case the sales rep was unable to determine which handpiece was the defective one.Sales rep is returning both handpieces and needs two replacements.Also, during the same procedure the 4 mm barrel bur plus seized up.After removed from the shoulder the inner blade was stuck in the outer blade.Swapped burr to resolve issue.The device had only been in use for approximately two minutes when the issue occurred.There was no patient harm but there was only 30 seconds surgical delay to the case to replace the burr with a new one.The devices will be returning for evaluation.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The complaint device was received and evaluated.The complaint cannot be confirmed.A visual inspection was performed to determine if the device had any gross visual defects that may contribute to the reported failure.No gross visual defects were observed on the device.However, residue was found on the device signifying that this device was used in the procedure.With the information provided and no anomalies observed on the device, we cannot determine a definitive root cause as to why the reported failure was experienced.Furthermore, a manufacturing record evaluation was performed for the finished device lot number (m1812031), and no non-conformances were 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.Device history : a manufacturing record evaluation was performed for the finished device [m1812031] number, and no non-conformances were identified.E1-e4: initial reporter is company representative.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.

• Brand Name: BARREL BURR 4.0MM 5PK
• Common Device Name: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9158310
• Report Number: 1221934-2019-58805
• Device Sequence Number: 1776523
• Product Code: HRX
• UDI-Device Identifier: 10886705022045
• UDI-Public: 10886705022045
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K041824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

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: 11/30/2023
• Device Catalogue Number: 283469
• Device Lot Number: M1812031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 11/04/2019
• Patient Sequence Number: 1