MAUDE Adverse Event Report: DEPUY MITEK MITEK FULL RADIUS CUTTER (LIGHT YELLOW) 3.5MM; ARTHROSCOPIC SHAVER BLADE

Catalog Number 283305

Device Problem Metal Shedding Debris (1804)

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

Event Date 08/11/2015

Event Type  malfunction  

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.In process.

Event Description

The sales rep reported that during a knee repair that two of his full radius cutters, 3.5mm, light yellow would clog after a minute of use and shoot metal shavings everywhere in the patient's joint space.The sales rep reported that all the shavings were removed with the shaver.The surgeon completed the procedure with no patient consequences.There was a 15 minute delay in the procedure.See associated medwatch # 1221934-2015-00959.

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 sales rep reported that during a knee repair that two of his full radius cutters, 3.5mm, light yellow would clog after a minute of use and shoot metal shavings everywhere in the patient's joint space.The sales rep reported that all the shavings were removed with the shaver.The surgeon completed the procedure with no patient consequences.There was a 15 minute delay in the procedure.See associated medwatch # 1221934-2015-00959.

Manufacturer Narrative

Three unused samples of the same lot as the complaint device were received and evaluated.Visual observation revealed no anomalies and no tissue debris or signs of use on all three devices.There was no structural damage that was noted.When the inner and outer shafts were mated, they rotated freely.Typically, metal shavings are associated with excessive friction between the inner and outer shaft.This can be usually caused by off-axis insertion or excessive application of force while using the device.The reported complaint could not be confirmed as the used devices were not returned for evaluation.Further, a review into the mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.At this point, 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 sales rep reported that during a knee repair that two of his full radius cutters, 3.5mm, light yellow would clog after a minute of use and shoot metal shavings everywhere in the patient's joint space.The sales rep reported that all the shavings were removed with the shaver.The surgeon completed the procedure with no patient consequences.There was a 15 minute delay in the procedure.See associated medwatch # 1221934-2015-00959.

• Brand Name: MITEK FULL RADIUS CUTTER (LIGHT YELLOW) 3.5MM
• Type of Device: ARTHROSCOPIC SHAVER BLADE
• 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: 5065534
• MDR Text Key: 25343268
• Report Number: 1221934-2015-00958
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Report Date: 08/11/2015

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 Catalogue Number: 283305
• Device Lot Number: M150320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/11/2015
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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