MAUDE Adverse Event Report: DEPUY MITEK 4 MM AGGRESSIVE BLADE PLUS; FMS BLADES & BURRS

Catalog Number 283419

Device Problem Metal Shedding Debris (1804)

Patient Problem No Information (3190)

Event Date 02/25/2016

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Associated medwatch for other devices used in this procedure: 1221934-2016-10117, 1221934-2016-10118, 1221934-2016-10120 and 1221934-2016-10121.(b)(4).The lot expiration date is currently unavailable.Awaiting device return.

Event Description

During a meniscal resection the shaverblade leaves cuttings in the knee (picture comes with the blade ).

Manufacturer Narrative

Five complaint devices were received and evaluated.All five devices are from the same lot.Visual observation of two of the five devices, revealed no anomalies with the blades, or the sleeves surface.The inner and outer sleeves were separated and inspected for any damage for the other three devices.All three devices had signs of friction and striation marks on the surface of the distal end of the inner sleeve.The friction marks indicate excessive friction between the sleeves, which could lead to metal shavings as reported.Therefore, the reported failure can be confirmed.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed no other complaint of any type for this lot of devices that were released to distribution.A white paper was performed previously on this failure and 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: 4 MM AGGRESSIVE BLADE PLUS
• Type of Device: FMS BLADES & BURRS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808210
• MDR Report Key: 5536743
• MDR Text Key: 41513535
• Report Number: 1221934-2016-10119
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK13191
• 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
• Report Date: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 283419
• Device Lot Number: M1508030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 02/29/2016
• Initial Date Manufacturer Received: 02/29/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other