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

Catalog Number 283419

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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 Description

It was reported by the sales rep via phone that during a rotator cuff repair procedure the customer's 4mm aggressive blade plus created metal shavings in the patient's joint space.The sales rep stated that all the metal shavings were removed by using another shaver and no debris was left in the patient.The procedure was completed by using a different shaver.There was no patient harm or surgical delay to the case.The device will be returning for evaluation.

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 is not being returned, multiples attempts for product return were made with no response, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device [m1901024] number, and no non-conformances were identified.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.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 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: AGGRESSIVE 4.0MM 5PK
• Type of Device: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9344323
• MDR Text Key: 208367750
• Report Number: 1221934-2019-59606
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705022021
• UDI-Public: 10886705022021
• Combination Product (y/n): N
• PMA/PMN Number: K041824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 283419
• Device Lot Number: M1901024
• Date Manufacturer Received: 12/05/2019
• Patient Sequence Number: 1