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

Catalog Number 283469

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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 affiliate via cst tool that during an unknown procedure the burr stopped rotating.The procedure was completed with no patient harm or time delay.

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.Investigation summary: the complaint device was received and inspected.The complaint can be confirmed.An attempt was made to rotate the inner shaft inside the outer shaft, however it was observed that the inner and outer shafts were jammed.When proper fluid management is not maintained while using the device, friction between the two shafts can cause heat to build up between the inner and outer shafts.Also, tissue debris can build up between the inner and outer shafts when proper fluid management is not maintained.When excessive tissue builds up between the two shafts, the shafts can become jammed.However, given the information provided we cannot discern a definitive root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance was identified.At this point, 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.

Event Description

Further it was reported that it was rotator cuff repair procedure.

• 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
• MDR Report Key: 8356221
• MDR Text Key: 136801919
• Report Number: 1221934-2019-56452
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705022045
• UDI-Public: 10886705022045
• 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: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 283469
• Device Lot Number: M1811024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Date Manufacturer Received: 03/26/2019
• Patient Sequence Number: 1