MAUDE Adverse Event Report: OSTA BURR, 4MM, 70DEG, DIAMOND TAPER, 5/PK

Model Number BUR4070DT

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 09/05/2016

Event Type  malfunction  

Manufacturer Narrative

At the time of this report, the device has not yet been returned for evaluation.As a result, a determination cannot be made at this time.If further information becomes available, gyrus acmi will continue the investigation and update the agency accordingly.

Event Description

Customer reported two burr¿s malfunctioned during operation.Front part of burr broke off.(this is one of two reports, see report # 01811 for the first device).

Manufacturer Narrative

Reviewed dhr for bur4070dt, lot number ih799335, manufactured 26oct2013.All assembly and post assembly tests were performed and recorded and all acceptance criteria were met with no indication of production or manufacturing issues.The returned sample was physically evaluated and the reported observation was confirmed.The returned sample shows evidence of the burr tip abrading the id of the outer sleeve at the tip area.It appears that the tip of the burr may have seized in the outer sleeve and stopped turning or turned slower than the inner wrap of the flexible burr which resulted in the flexible wraps of the burr breaking.Per dfmea 09-016 , id#4, id#5, id# 6, id#7, and id#85, inner blade reliability is identified as a recognized potential failure mode.The identified potential effect of the failure is surgeon dissatisfaction and delay of procedure.Potential causes include excessive loading of the burr during use, inadequate grease (lubricant between the inner and outer blade), insufficient irrigation during use, and improper design.The cause of the reported observation could not be conclusively determined, but based on the findings it appears to be related to excessive loading force applied on the burr.The complaint history was reviewed for the time period of 01april2013 through 01may2017 for all sizes of burrs.Across the entire burr product family, there was only one similar report recorded in april 2015 and it also was for a bur4070dt, lot number ih796865 that was manufactured 08nov2013.Based upon the 4 year complaint history review, the reported failures are isolated and have not occurred frequently enough to require corrective action.Trending will continue to be monitored monthly by capa boards which determine if additional action is required.

• Brand Name: BURR, 4MM, 70DEG, DIAMOND TAPER, 5/PK
• Manufacturer (Section D): OSTA; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: terrence sullivan ; 136 turnpike road; southborough, MA 01772 ; 508804-273
• MDR Report Key: 6380692
• MDR Text Key: 69502737
• Report Number: 1037007-2017-00001
• Device Sequence Number: 1
• Product Code: HTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT-EQJ
• 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: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BUR4070DT
• Device Lot Number: IH799335
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1