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

Catalog Number 283429

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2019

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.Udi:(b)(4).Incomplete the expiration date is unknown.

Event Description

It was reported by the sales rep via cst that there is metal shedding on the ultra aggressive plus 4.0mm 5pk.The procedure was successfully completed.Fragments were generated, however they had been easily removed from the patients body.No additional information has been provided.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: the complaint device was received for evaluation.Visual observation of the complaint device reveals no anomalies to the outer shaft.When the inner shaft was examined, the cutting surfaces showed wear marks which indicates excessive friction and indicates that the device might have hit a hard surface, or an excessive lateral force was applied to the device during use, which could lead to metal shavings as reported, confirming the complaint.No further information regarding the cause of the defect has been provided to help determine the root cause for this failure.A manufacturing record evaluation was performed for the finished device m1902024 number, 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.A manufacturing record evaluation was performed for the finished device m1902024 number, and no non-conformances were identified.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: ULTRA AGGRESSIVE PLUS 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: 9105601
• MDR Text Key: 203981725
• Report Number: 1221934-2019-58453
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705022229
• UDI-Public: 10886705022229
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 283429
• Device Lot Number: M1902024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Date Manufacturer Received: 11/20/2019
• Patient Sequence Number: 1