MAUDE Adverse Event Report: DEPUY MITEK FULL RADIUS CUTTER (LIGHT YELLOW) 3.5 MM; MITEK FMS BLADES & BURRS

Catalog Number 283305

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/09/2016

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.(b)(4).The lot expiration date is currently unavailable.

Event Description

The sales rep reported that during a shoulder procedure the customer's full radius cutter (light yellow) 3.5mm was created massive amounts of metal shavings in the patient's joint.The sales rep stated that the surgeon removed as much of the metal shavings as they could.The sales rep reported that the surgeon completed the procedure with another like device with no patient consequences but there was an eight minute delay.The sales rep was not present for the case therefore could not provide any further information.The sales rep stated that the surgeon discarded the device.

Manufacturer Narrative

The complaint device is not being returned, therefore unavailable for a physical evaluation.Nineteen unused devices from the same lot were sent back.Five devices were visually and functionally tested out of the returned samples.Visual observation of all of the five devices, revealed no anomalies with the blades, or the sleeves surface.The first sample was connected to the fms vue pump and activated in saline solution.No metal shavings/particles were observed in the saline solution.The device was inspected again after the functional test, and no anomalies were found.The test was repeated for the other four samples, and they passed the visual and functional testing.The reported complaint cannot 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

• Brand Name: FULL RADIUS CUTTER (LIGHT YELLOW) 3.5 MM
• Type of Device: MITEK 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: 5759594
• MDR Text Key: 48469343
• Report Number: 1221934-2016-10268
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK041824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 283305
• Device Lot Number: M1603013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2016
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other