MAUDE Adverse Event Report: DEPUY MITEK LLC US 4 MM ROUND TORNADO BURR PLUS; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Model Number 283479

Device Problems Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Not Applicable (3189)

Event Date 08/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device returned.Occupation: synthes rep.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that during a shoulder arthroscopy, small particles came loose.Therefor, the procedure was prolonged.This report is 1 of 1 for (b)(4).

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 device was received for evaluation.Visual inspection under magnification reveals that there are some wear areas inside of the outer hub assembly.There were no other anomalies on the rest of the outer hub assembly.There were no anomalies observed on the inner hub assembly.It appears that the blades look like they have come in contact with a hard surface that caused the shavings.Also, it seems that an excessive lateral force was placed on the blades during use that would also have caused this failure.This complaint can be confirmed.These would be the root cause of the failure.A manufacturing record evaluation was performed on 9/11/2019 for the finished device m1904006 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 on 9/11/2019 for the finished device m1904006 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: 4 MM ROUND TORNADO BURR PLUS
• 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: 9079016
• MDR Text Key: 159042606
• Report Number: 1221934-2019-58373
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705025435
• UDI-Public: (01)10886705025435
• Combination Product (y/n): N
• PMA/PMN Number: K131191
• 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: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 283479
• Device Catalogue Number: 283479
• Device Lot Number: M1904006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Date Manufacturer Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1