MAUDE Adverse Event Report: DEPUY MITEK ULTRA AGGRESSIVE PLUS 5.0 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Catalog Number 283729

Device Problems Particulates (1451); Metal Shedding Debris (1804)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Depuy synthes has been informed that the lot number is not available.

Event Description

It was reported that metal abrasion using shaver there were no patient consequences the information being submitted for this complaint is all of the details that are known/available regarding this event.

Manufacturer Narrative

Product complaint # (b)(4).Device was used for treatment, not diagnosis.Additional narrative: udi: (b)(4).

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 additional information should become available, a supplemental medwatch will be submitted accordingly.Correction: manufacturer name, city and state, mfr site, report source: the manufacturer contact name has been updated as (b)(6).Contact phone number and email address have been updated accordingly.Additional information: investigation summary: the complaint device was received and inspected.The complaint was confirmed.The device was forwarded to supplier quality engineering for further investigation.The supplier quality engineer indicated that when the device was rotated there was a slight resistance felt in both directions.There was a chip on the inner tooth tip of the device, along with wear lines on the distal tip.The supplier indicated that all machining steps including electropolish, greasing and heat treatment were performed according to specification.Inspection for concentricity, hardness and dimensional analysis that is critical to quality (ctq) showed no signs of anomalies that would contribute to the reported failure.Processing steps and equipment were investigated, and all steps were performed without incident or changes to the equipment including non-standard preventative maintenance (pm).Given the information provided we cannot discern a definitive root cause for the reported failure.A non-conformance was initiated to further investigate the failure at the supplier.The device history record (dhr) review indicated that non-conformance conditions were identified, however the issues were found to be unrelated to the complaint condition.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 5.0 5PK
• Type of Device: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7486651
• MDR Text Key: 107349292
• Report Number: 1221934-2018-50558
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705022083
• UDI-Public: 10886705022083
• Combination Product (y/n): N
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 283729
• Device Lot Number: M1710012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1