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

Catalog Number 283419

Device Problem Metal Shedding Debris (1804)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device was used for treatment, not diagnosis.Investigation summary: product was not returned and thus not available for physical evaluation.Hence, the reported complaint cannot be confirmed.Furthermore, no lot number was supplied which precludes conducting a device history record review or a lot specific search in the complaints handling system.No further information regarding this event has been provided to determine a root cause for this failure.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.(b)(4) -incomplete.Depuy synthes has been informed that the lot number is not available.

Event Description

It was reported by the sales rep that there was metal wear using shaver.The following information was obtained from the sales rep via e-mail on 4-25-2018: the metal shavings occurred during procedure but it is not clear as to which anatomic region of the knee or in which stage it occurred.There was a delay less than 30 minutes to the procedure.The procedure was completed with the same device.Alternatives were also readily available.Not clear if there were any procedural or patient anatomy factors which might have affected the breakage.It is possible that the anatomical structure of the knee was narrow, but not sure.No surgical intervention is planned.All the particles that were in the patient joint were removed with shaver suction.No known patient impact at this stage.

• Brand Name: 4 MM AGRESSIVE BLADE PLUS
• Type of Device: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7464568
• MDR Text Key: 107223647
• Report Number: 1221934-2018-50529
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705022021
• UDI-Public: 10886705022021
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K041824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 283419
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2018
• 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