MAUDE Adverse Event Report: DEPUY MITEK MITEK FMS 5.0MM ULTRA-AGGRESSIVE BLADE PLUS, TORNADO HUB; ARTHROSCOPIC INSTRUMENT

Catalog Number 287529

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Unknown (for use when the patient's condition is not known) (2202)

Event Date 01/07/2014

Event Type  malfunction  

Event Description

Our affiliate is reporting the following to us: ¿longer procedure and particulates release.During its use, the shaver released metallic particles inside the knee.The packaging of 8 shavers were opened but each one presented, the same issue.Some metallic debris were sticking to tissues.They stopped using the sheaver" also see associated mdrs 1221934-2014-00007, 1221934-2014-00008, 1221934-2014-00009, 1221934-2014-00010, 1221934-2014-00011, 1221934-2014-00012 and 1221934-2014-00014.

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 awaiting return.

Manufacturer Narrative

The complaint device has not been returned, therefore is unavailable for a physical evaluation.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 of any kind for this lot of (b)(4) devices that were released to distribution.We cannot discern a root cause for the reported failure mode; although one possible root cause could be the reuse of the single use device.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.

Event Description

Our affiliate is reporting the following to us: ¿longer procedure and particulates release.During its use, the shaver released metallic particles inside the knee.The packaging of 8 shavers were opened but each one presented the same issue.Some metallic debris were sticking to tissues.They stopped using the shaver." also see associated mdrs 1221934-2014-00007, 1221934-2014-00008, 1221934-2014-00009, 1221934-2014-00010, 1221934-2014-00011, 1221934-2014-00012 and 1221934-2014-00014.

• Brand Name: MITEK FMS 5.0MM ULTRA-AGGRESSIVE BLADE PLUS, TORNADO HUB
• Type of Device: ARTHROSCOPIC INSTRUMENT
• 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: 3579009
• MDR Text Key: 4161967
• Report Number: 1221934-2014-00013
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131191
• 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
• Report Date: 01/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2014
• 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: 287529
• Device Lot Number: M1305015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/10/2014
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2014
• Date Manufacturer Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1