MAUDE Adverse Event Report: DEPUY MITEK 5 MM ULTRA AGGRESSIVE PLUS; FMS BLADES & BURRS

Catalog Number 283729

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2016

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).The lot expiration date is not currently available.

Event Description

The sales rep reported that prior to a shoulder procedure after opening the package to their ultra aggressive plus 5.0, when connecting the device to the handpiece on the back table it was that found that there was a small piece of foreign substance on the device.The sales rep stated that the substance was a piece of thread.The sales rep reported that the thread was only noticed when the blade was being connected to the handpiece, it was not noticed when the device package was opened.The sales rep also stated that there were towels on the back table which the thread could have come from, however the actual source is unknown.The sales rep reported that the surgeon completed the procedure with another like device with no patient consequences or delays.The sales rep was not present for the case therefore could not provide any further information.The sales rep stated that the facility discarded the piece of thread and all that will be returning for evaluation is the device itself.

Manufacturer Narrative

The complaint device is not available for a physical evaluation.However it has been reported that the foreign particle may have got on to the device while on the back table.It cannot be confirmed that the particle was out of box.A batch record review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.At this point in time, no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.Depuy 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.(b)(4).

• Brand Name: 5 MM ULTRA AGGRESSIVE PLUS
• Type of Device: FMS BLADES & BURRS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 5975647
• MDR Text Key: 55568103
• Report Number: 1221934-2016-10396
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2016

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: 01/31/2019
• Device Catalogue Number: 283729
• Device Lot Number: M1402003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2016
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 09/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/21/2014
• 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