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

Model Number 283419

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 02/10/2020

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 8 of the aggressive 4.0 mm 5 pk released metallic debris in the joint.There was no patient consequence, however there was a 5 minutes surgical delay.The procedure was completed washing the joint.No additional information was provided.

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: correction: d1, d4: the brand name and catalog have been updated accordingly to reflect the correct information.Therefore, udi: (b)(4).Additional information: h4: the device manufacture date was reported as unknown on the initial report and has been updated accordingly.Device evaluation: investigation summary
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> according to the information provided, it was reported that 8 ultra aggressive blades released metallic debris in the joint during the procedure.The complaint devices were received and evaluated.Visual observations confirm that 7 blades were received new in the original package and sealed; the sterility was not compromised.The blade received used, was evaluated and no anomalies were found.Further investigation under magnification revealed no anomalies, some marks of use were observed.No other anomalies were identified.Therefore the complaint was not confirmed.A possible root cause for the reported failure can be attributed to interaction between two metal devices that could precludes the devices to function as intended, however this cannot be conclusive determined.As there is no indication that a potential cause is associated to manufacturing, a manufacturing record evaluation is not required.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.

• 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: 9744957
• MDR Text Key: 205508939
• Report Number: 1221934-2020-00662
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705022021
• UDI-Public: 10886705022021
• 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: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283419
• Device Catalogue Number: 283429
• Device Lot Number: M1906037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Date Manufacturer Received: 04/14/2020
• Patient Sequence Number: 1