MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-11 for OSTEOPOWER 450-0777 manufactured by Osteomed.
[97053819]
The root cause of this investigation is related to product wear. The evaluation of the device showed that the device has not been properly maintained, as recommenced within osteomed labeling. Per the sro diagnostic, the unit was overheating due to damaged bearings. A review of service history records shows that the device has not been returned to osteomed since 2014. When the bearing froze up, this generated excessive heat in the drill. Residual oil from routine lubrication then heated up and upon leaching down the shaft of the burr, the heated oil was spun off the rotating burr and sprayed into the patient's mouth. During the procedure, the overheated unit made contact with the patient's lip, which caused the burn to the lip. The review of the osteopower handpiece system product information and instructions for use provides instructions for maintaining device effectiveness and cleaning. It also includes a functionality test to check for "unusual performance, sounds, vibrations or excessive heat build-up. A review of the osteopower surgical handpiece system operating instructions and maintenance manual shows that osteomed recommends that all osteopower handpiece components be examined every twelve (12) months for preventive maintenance. More specific to 450-0777, the use of the 450-0777 with contaminated and/or worn bearings may rapidly generate heat and cause patient injury. Failure to clean and lubricate properly, and return to osteomed for periodic maintenance can lead to contaminated bearings that can fail and generate excessive heat. The review of the dhr did not identify any non-conformances with lot release. The review of capas identified one (1) capa related to this complaint. The corrective actions were implemented in 2014. This unit was manufactured in 2006. The osteopower system fmea includes an assessment of this type of failure mode. The overall risk level score is low. This issue will be monitored through routine trending. Qa note: during an audit of mdr submissions, we identified that there was an error on the initial submission and follow-up reports that prevented upload to (b)(6). Therefore, this report is being re-submitted. Date of original submission report: 11/29/2016. Date of follow-up submission report: 01/24/2017
Patient Sequence No: 1, Text Type: N, H10
[97053820]
On (b)(6) 2016, osteomed was notified of an incident concerning a patient burn that occurred on (b)(6) 2016. During a surgical procedure, the series iii straight drill (p/n 450-0777) overheated. Oil sprayed from the unit into the patient's mouth, and the heat of the unit caused a burn to the patient's lip. Per a follow up with the physician, the patient experienced a post- operative intraoral infection. The infection was treated and the burn has healed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027754-2016-00010 |
| MDR Report Key | 7184006 |
| Date Received | 2018-01-11 |
| Date of Report | 2016-11-29 |
| Date of Event | 2016-10-26 |
| Date Mfgr Received | 2016-11-02 |
| Device Manufacturer Date | 2006-12-27 |
| Date Added to Maude | 2018-01-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. LATOIA PHILLIPS |
| Manufacturer Street | 3885 ARAPAHO ROAD |
| Manufacturer City | ADDISON TX 75001 |
| Manufacturer Country | US |
| Manufacturer Postal | 75001 |
| Manufacturer G1 | OSTEOMED |
| Manufacturer Street | 3885 ARAPAHO ROAD |
| Manufacturer City | ADDISON TX 75001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OSTEOPOWER |
| Generic Name | SERIESS III STRAIGHT DRILL |
| Product Code | KMW |
| Date Received | 2018-01-11 |
| Returned To Mfg | 2016-11-29 |
| Catalog Number | 450-0777 |
| Lot Number | 1013634 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTEOMED |
| Manufacturer Address | 3885 ARAPAHO ROAD ADDISON TX 75001 US 75001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-11 |