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

Model Number 283489

Device Problems Mechanical Jam (2983); Suction Failure (4039)

Patient Problems Edema (1820); Not Applicable (3189)

Event Date 01/08/2020

Event Type  Injury  

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).

Event Description

It was reported by affiliate via email, that during an arthroscopic shoulder surgery (subacromial decompression, clavicle resection) the shaver blad started to sound strange, had bad suction and stopped working.When the blade was taken out of the handpiece, the inner and outer parts were stuck together and could not be separated.The blade was replaced with a similar one, but the procedure was prolonged 15 min.The surgeon experienced a bit more swelling than normal.

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.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.H10 additional narrative: additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that there was no problems with the fms vue.Only the shaver blade had the issue.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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.H10 additional narrative: additional information: investigation summary
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> according to the information provided, it was reported that the barrel tornado, started to sound strange, had bad suction and stopped working.The complaint device was received and evaluated.Visual observations confirm that burr inner blade was jammed inside the outer shaft and was corroded, functional testing,was performed, once connected at pump, was observed that the device was jammed and made strange sounds, the complaint can be confirmed.The possible root cause for the reported failure can be occur if the surgeon does not utilize proper irrigation during use of the device.When the proper irrigation is not utilized, the blade surface can heat up from the friction between the inner blade and outer sheath therefore causing a cold-type weld to occur.However, this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device [m1907056] 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.Device history lot
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> a manufacturing record evaluation was performed for the finished device [m1907056] number, and no non-conformances were identified.

• Brand Name: BARREL TORNADO 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: 9588543
• MDR Text Key: 187590111
• Report Number: 1221934-2020-00196
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705022052
• UDI-Public: 10886705022052
• Combination Product (y/n): N
• PMA/PMN Number: K041824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283489
• Device Catalogue Number: 283489
• Device Lot Number: M1907056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Date Manufacturer Received: 03/15/2020
• Patient Sequence Number: 1