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

Catalog Number 283429

Device Problem Peeled/Delaminated (1454)

Patient Problems Foreign Body In Patient (2687); Not Applicable (3189)

Event Date 02/18/2019

Event Type  Injury  

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.Udi: (b)(4)-incomplete.The expiration date is unknown.

Event Description

It was reported by the affiliate via cst that during arthroscopy with ultra aggressive plus 4 mm, the surgeon had a big metal abrasion in the knee joint.It happened during the first random of the shaver blade.There were fragments generated but they were removed without additional intervention.Affiliate stated that there are still little pieces from the metal in the joint.Surgery completion details and medical intervention requirement are unknown.There was no patient consequences reported.It was unknown was surgery delayed or not.Additional information reported by the affiliate stated that there was a 5 minute surgical delay due to the event.It was also reported that the case was completed by using another readily available shaver blade.The affiliate also stated that there is no surgical intervention planned.

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.Investigation summary: the complaint device was received and inspected.The complaint can be confirmed.A visual inspection was performed to determine if the device had any gross visual defects that may contribute to the complaint condition.It was observed that the surfaces of the inner blade and outer hub were scratched in the lateral direction.To test the functionality of the device, the inner blade was rotated in both directions.From this operation, no notable resistance was detected.Per the ifu, proper irrigation must be maintained while the device is in use.If proper irrigation is not maintained, excessive friction can occur between the inner blade and the outer hub therefore causing metal particulate shedding.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.A white paper was performed previously on this failure; the result indicated that the amount of shedding for this product is acceptable.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.Udi: (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.

• 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: 8429822
• MDR Text Key: 139113103
• Report Number: 1221934-2019-56629
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 283429
• Device Lot Number: M1808018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Date Manufacturer Received: 03/27/2019
• Patient Sequence Number: 1