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

Model Number 283429

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Udi: (b)(4).

Event Description

It was reported by the affiliate via complaint submission tool that during an unknown procedure the ultra aggressive plus 4.0 mm 5pk had metallic debris.No patient consequence was reported, however there was a 5 minutes surgical delay.No additional information was provided.Additional information provided by the affiliate reported 15 blades were involved in this complaint and the event occurred when the shaver was turned on at the beginning of a knee arthroscopic surgery.There were no known user or patient impacts due to the metallic shavings and the case was completed with a new blade.The reporter also stated the fragments were easily removed by washing the joint and additional surgical intervention is not required.This is a duplicate report of submitted 1221934-2020-00609 and all event information can be found in 1221934-2020-00609.

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: investigation summary
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> according to the information provided, it was reported that during an unknown procedure the ultra aggressive plus 4.0mm 5pk had metallic debris.The complaint devices were received and evaluated.Visual observations confirm that the ultra aggressive blade plus devices were received in its original packaging and sealed, therefore the sterilization is not compromised.Only slight damages were observed in the boxes than can be attributed during handling or transportation.In addition, two packages were opened to ensure our inspection and metallic debris were not observed inside the boxes or in the blades.We cannot confirm this complaint or discern a root cause for the user to have experienced this issue.The possible root cause for the reported failure can be attributed to interaction between two devices that cannot rotate freely.However; this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device lot/serial number (b)(6), 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 lot/serial number (b)(6), and no non-conformances were identified.

• Brand Name: ULTRA AGGRESSIVE PLUS 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: 9741743
• MDR Text Key: 205268031
• Report Number: 1221934-2020-00643
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705022229
• UDI-Public: 10886705022229
• 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
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283429
• Device Catalogue Number: 283429
• Device Lot Number: M1905040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Date Manufacturer Received: 03/30/2020
• Patient Sequence Number: 1