MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 5.5MM ROUND BUR, LONG HIP BUR, FORMULA, 8 FLUTE (5BX); BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number 0385950008

Device Problem Overheating of Device (1437)

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

Event Date 03/13/2015

Event Type  malfunction  

Event Description

It was found that the inner shaft was hot enough to cause deformation of the proximal plastic hub.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Manufacturer Narrative

The reported device was not received for investigation; therefore the reported failure cannot be confirmed.The complaint will be closed without a detailed investigation report and based on probable root cause.In the event that the device is received, the complaint will be reopened, a full evaluation will be conducted, and the investigation will be updated with the new results.Probable root cause for the reported failure involving this device could have been caused by: manufacturing defect (grease application), high friction due to components interaction, surface not smooth, poor/lack of suction, clogged shaver blade preventing fluid suction and cooling.The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was found that the inner shaft was hot enough to cause deformation of the proximal plastic hub.

• Brand Name: 5.5MM ROUND BUR, LONG HIP BUR, FORMULA, 8 FLUTE (5BX)
• Type of Device: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: thomas shafer ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 4666200
• MDR Text Key: 5730461
• Report Number: 0002936485-2015-00279
• Device Sequence Number: 1
• Product Code: GFF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2015

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: 0385950008
• Device Lot Number: 15050CE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 04/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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