MAUDE Adverse Event Report: DEPUY MITEK ULTRA-AGGRESSIVE CUTTER SHAVER BLADES 5.0MM; FMS BLADES & BURRS

Catalog Number 287525

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/09/2016

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.Awaiting device return.

Event Description

The surgeon informed that the device was releasing microfragments during a shoulder arthroscopy.The image was atypical.In the image appear small gray dots that dr.(b)(6) describes as ¿microfragments of the blade shaver soft tissue ultra-aggressive cutter 5.0¿.The procedure was completed with same like product.

Manufacturer Narrative

The complaint device was received and evaluated.Visual observation revealed that the device¿s outer and inner shaft were bent severely.Additionally, striation markings were present along the shaft of the inner piece, confirming the reported condition.Typically, a bent shaft is indicative of misuse; due to the fact that the shaft is bent, when the blade is operated, there is increased friction between the inner and outer shaft which could lead to metal shavings as reported.However, in this case, it was confirmed that the device was bent on purpose by the end-user after use so a definitive root cause could not be determined.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 complaints for this lot of devices that were released to distribution.At this point, 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.

Event Description

Additional information received via email from the affiliate on 04/07/2016: the metal shavings were partially removed.The blade shaver was used to remove / aspirate them.The procedure was completed normally.This failure did not extend the procedure time greater than 30 minutes.The first picture of the cutter appears to be bent, do you know how that happened? as we previously reported the bending occurred in the practice of spilling the product after its use to avoid reprocessing, leaving the device totally unusable.

• Brand Name: ULTRA-AGGRESSIVE CUTTER SHAVER BLADES 5.0MM
• 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: 5546310
• MDR Text Key: 41817417
• Report Number: 1221934-2016-10129
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK954465
• 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: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 287525
• Device Lot Number: M1309038
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2016
• Date Manufacturer Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other