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

Catalog Number 287769

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The lot number is currently unavailable.Investigation summary: the complaint device was received and evaluated with an npd engineer.Visual observation shows that the device is not dull and when reviewed under magnification, the blades looked fairly new and were not dull.This complaint cannot be confirmed but it was observed that the inner and outer shaft are jammed.They were unable to be separated, the device requires adequate irrigation to avoid tissue from building up inside the shaft while also remaining at a temperature during operation that will not damage the device.If adequate irrigation is not used, debris can build up in between the two shafts and the friction caused by the spinning shafts can induce heat transfer and cause the two parts to cold weld together.However, given the information provided we cannot discern a definitive root cause for the reported failure.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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.

Event Description

It was reported by the affiliate in (b)(6) that during an unspecified arthrolysis procedure, it was observed that the barrel burr was dull and not sharp enough after a few minutes of use.During in-house engineering evaluation, it was determined that the inner and outer shaft were jammed.There was no delay as a spare device was available for use.It was reported that the device was not clogged and there were no metal shavings.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: BARREL BURR 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
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8199084
• MDR Text Key: 131520891
• Report Number: 1221934-2018-55854
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K131191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 287769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Date Manufacturer Received: 12/26/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1