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

Catalog Number 283729

Device Problems Material Disintegration (1177); Metal Shedding Debris (1804)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

The affiliate reported via email during the surgery, the 2 devices released small particles and it was not possible to continue the surgery with them.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the complaint device was received and forwarded to npd engineer for evaluation.Visual observation of the complaint device reveals no anomalies to the outer shaft.When the inner shaft was examined, the distal end showed multiple friction marks and slight damage, indicates excessive friction and indicates that the device might have hit a hard surface, or an excessive lateral force was applied to the device during use, which could lead to metal shavings as reported, confirming the complaint.A review of the device history record indicated that this batch of products was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the depuy synthes mitek complaints system revealed one other similar complaint for this lot of devices that were released to distribution.The only two failures identified for this lot are on this complaint.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 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.Udi: (b)(4).

• Brand Name: ULTRA AGGRESSIVE PLUS 5.0 5PK
• Type of Device: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 6983053
• MDR Text Key: 90789092
• Report Number: 1221934-2017-10633
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2017,01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 283729
• Device Lot Number: M1704021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2017
• Initial Date Manufacturer Received: 09/29/2017
• Initial Date FDA Received: 10/27/2017
• Supplement Dates Manufacturer Received: 01/19/2018; 08/27/2018
• Supplement Dates FDA Received: 01/23/2018; 08/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1