MAUDE Adverse Event Report: DEPUY MITEK MITEK 4.0MM FULL RADIUS BLADE PLUS; BLADES & BURRS (CROSSCUT)

Catalog Number 283409

Device Problem Device, or device fragments remain in patient (1527)

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

Event Date 05/15/2015

Event Type  Injury  

Event Description

The shaver left a significant amount of metal shaving from the friction of the shaver consumable rubbing together whilst in use.The function of the shaver was not impaired nor did it make any grinding noise.At the end of the case it was noticed the shaver had deposited a significant amount of metal shavings within the joint.Wash out / suctioned the joint thoroughly to remove as much metal shavings as possible.See associated medwatch # 1221934-2015-00825.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy synthes mitek, however, it is not known if it will be received within the 30 day reporting requirement, therefore, depuy synthes 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.

Manufacturer Narrative

Two complaint devices were received and forwarded to npd engineer for evaluation.Visual observation of the complaint devices reveals no anomalies to the outer shafts.When the inner shafts were examined for both, signs of friction between the two shafts were seen.The friction marks indicates excessive friction, which could lead to metal shavings as reported.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 an 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.A white paper was performed previously on this failure; 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.

Event Description

The shaver left a significant amount of metal shaving from the friction of the shaver consumable rubbing together whilst in use.The function of the shaver was not impaired nor did it make any grinding noise.At the end of the case it was noticed the shaver had deposited a significant amount of metal shavings within the joint.Wash out / suctioned the joint thoroughly to remove as much metal shavings as possible.See associated medwatch # (b)(4).

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy synthes mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy synthes 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.

Event Description

The shaver left a significant amount of metal shaving from the friction of the shaver consumable rubbing together whilst in use.The function of the shaver was not impaired nor did it make any grinding noise.At the end of the case it was noticed the shaver had deposited a significant amount of metal shavings within the joint.Wash out / suctioned the joint thoroughly to remove as much metal shavings as possible.See associated medwatch # 1221934-2015-00825.

• Brand Name: MITEK 4.0MM FULL RADIUS BLADE PLUS
• Type of Device: BLADES & BURRS (CROSSCUT)
• 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: eric so ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4839093
• MDR Text Key: 18034581
• Report Number: 1221934-2015-00826
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,company repres
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 283409
• Device Lot Number: M1408036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/15/2015
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2015
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other