MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-06 for BURR, 4MM, 70DEG, DIAMOND TAPER, 5/PK BUR4070DT manufactured by Osta.
[69502737]
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.
Patient Sequence No: 1, Text Type: N, H10
[69502738]
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)
Patient Sequence No: 1, Text Type: D, B5
[75935170]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1037007-2017-00001 |
| MDR Report Key | 6380692 |
| Date Received | 2017-03-06 |
| Date of Report | 2017-05-11 |
| Date of Event | 2016-09-05 |
| Date Mfgr Received | 2017-05-11 |
| Device Manufacturer Date | 2013-10-26 |
| Date Added to Maude | 2017-03-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 508804-273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BURR, 4MM, 70DEG, DIAMOND TAPER, 5/PK |
| Product Code | HTT |
| Date Received | 2017-03-06 |
| Returned To Mfg | 2017-03-22 |
| Model Number | BUR4070DT |
| Lot Number | IH799335 |
| ID Number | UDI |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTA |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-06 |