MAUDE Adverse Event Report: DEPUY MITEK MITEK FMS MINI ULTRA AGGRESSIVE, 3.5 X 80, STRAIGHT; FMS BLADES & BURRS

Catalog Number 287375

Device Problem Tip breakage (1638)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2014

Event Type  malfunction  

Event Description

Our affiliate is reporting the following to us: during the elbow arthroscopy the distal part of outer sleeve of the mini ultra-aggressive cutter shaver blade released.The surgeon had to order the x-ray department to find the end part of the outer sleeve of the blade and finally found it.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek however is not known if it will be received within the 30 day reporting requirement, therefore depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.Device eval: awaiting receipt.

Manufacturer Narrative

The complaint device was received and evaluated.Visual inspection indicates the device returned is fully intact and the distal end of the outer sleeve is not broken.It cannot be confirmed at this time if the correct complaint device was returned.A batch record review has been conducted and the 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 mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.However, 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.Should the complaint device be returned at any time in future, this complaint will be reopened and a thorough investigation will be conducted.

Event Description

Our affiliate is reporting the following to us: during the elbow arthroscopy the distal part of outer sleeve of the mini ultra-aggressive cutter shaver blade released.The surgeon had to order the x-ray department to find the end part of the outer sleeve of the blade and finally found it.

Manufacturer Narrative

The complaint device was received and evaluated.Visual inspection confirms the distal tip portion of the outer shaft is detached.There is no indication of any excess force or any rough edges on the distal tip that would indicate the device was misused.A batch record review has been conducted and the 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 mitek complaints system revealed no similar complaints for this lot of devices or for this product code in the last 2 years.This failure seems to be an anomaly and a one off incident and there is no indication of any discrepancies in the manufacturing of this lot that would contribute to this failure.At this point, based on the complaint history, no further action is warranted.However, 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.

Event Description

Our affiliate is reporting the following to us: during the elbow arthroscopy the distal part of outer sleeve of the mini ultra-aggressive cutter shaver blade released.The surgeon had to order the x-ray department to find the end part of the outer sleeve of the blade and finally found it.

• Brand Name: MITEK FMS MINI ULTRA AGGRESSIVE, 3.5 X 80, STRAIGHT
• Type of Device: FMS BLADES & BURRS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: david primmerman ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 3598152
• MDR Text Key: 4065047
• Report Number: 1221934-2014-00047
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2014

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: 04/30/2018
• Device Catalogue Number: 287375
• Device Lot Number: M1305014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/17/2014
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2014
• Initial Date Manufacturer Received: 01/17/2014
• Initial Date FDA Received: 01/29/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/19/2014; 05/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2013
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention