MAUDE Adverse Event Report: BRASSELER USA, MEDICAL L.L.C. BRASSERLER USA MEDICAL, LLC MILLING HANDPIECE; SURGICAL MILLING HANDPIECE

Model Number ZIMMER MILL 00-5927-040-00 REV E

Device Problems Partial Blockage (1065); Break (1069); Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Date 05/06/2015

Event Type  malfunction  

Event Description

Surgery was being done at (b)(6) surgery center.Patient was prepared for the pfj procedure and the incisions were made.Representative opened disposable instruments (screws and burr) for surgery.Attempt was made to insert burr into handpiece (lot 08010104) and it could not be done.It appears that a burr had broken off in a previous surgery.The broken piece cannot be pulled out of the handpiece.The second hand piece (lot 08010207) was brought out to be used.This handpiece is jammed and does not turn.Patient had to be closed up and moved to (b)(6) hospital.Surgery was completed on (b)(6) 2015.

Manufacturer Narrative

Follow up: the handpiece was evaluated and was identified to be in extremely poor condition, showing excessive corrosion and rust.The handpiece was sold to customer in (b)(6) of 2008.There is no record of this handpiece being returned to brasseler for service/preventive maintenance.It appears that the handpiece has not received any preventive maintenance.The operating instructions for use recommends preventive maintenance every 6 months.This failure is attributed to an extended lapse of service/preventive maintenance.

• Brand Name: BRASSERLER USA MEDICAL, LLC MILLING HANDPIECE
• Type of Device: SURGICAL MILLING HANDPIECE
• Manufacturer (Section D): BRASSELER USA, MEDICAL L.L.C.; 4837 mcgrath st.; ventura CA 93003
• Manufacturer (Section G): BRASSELER USA, MEDICAL L.L.C.; 4837 mcgrath st.; ventura CA 93003
• Manufacturer Contact: kenneth jones ; one brasseler blvd.; savannah , GA 31419 ; 9129217501
• MDR Report Key: 4808093
• MDR Text Key: 5829210
• Report Number: 2025102-2015-00002
• Device Sequence Number: 1
• Product Code: HSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,distributor,health prof
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2015

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 Model Number: ZIMMER MILL 00-5927-040-00 REV E
• Device Catalogue Number: 00-5927-040-00

Device Lot Number

• Was Device Available for Evaluation?: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 05/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization