MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-01-11 for OSTEOPOWER 450-0777 manufactured by Osteomed.
[97016089]
The exact root cause is undetermined. Both devices were submitted to osteomed on 05/30/2013 under (b)(4). The sro documents that 450-0777, s/n (b)(4) overheats. The other 450-0777 device does not indicate overheating. It states that the module shut down the console. Though it appears that the device documented as overheating was used during this case, that information is not specifically known. The diagnostic of both units show that the distal bearing was broken. Bearings will fail when the accumulation of debris within the device reaches a level that they no longer spin freely. This causes heat to build up and eventually either break or seize up and stall (shut down) the console. The console is equipped with a over-current protection and automatically shuts-down when the current drawn by motor unit an module goes over 5-6 amps. The diagnostic of these devices show that both exhibited bearing failure. Per the results of in internal capa, bearing failures can be caused by the following conditions:? Friction due to vibration or debris, or excessive wear? Poor/ineffective maintenance and lubrication? Out of round, or excessively worn front housing. The corrective action recommendations concerning this capa were implemented in 2014. These devices were manufactured prior to 2014 - 2002 and 2003. The review of the dhrs did not identify any non-conformances concerning this issue. No ncrs were identified for this issue. The review of complaints identified three similar issues of patient burn. However, two are included in the capa. The series iii straight drill is a reusable device within the osteopower product family. The review of the osteopower handpiece system product information and instructions for use (030-1106) provides instructions for maintaining device effectiveness and cleaning. It also instructs the user to review the osteopower surgical handpiece system operating instructions and maintenance manual (030-1179) prior to use. A review of the manual shows that osteomed recommends that all osteopower handpiece components be examined every twelve (12) months for preventive maintenance. The service histories for these devices show that they had not been returned to osteomed since 2010. 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. The straight drill must be thoroughly cleaned and lubricated after each use to prevent bearing contamination. 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.. Per the osteopower 2i system risk assessment and fmea file, this type of failure mode has a risk level score of low. This issue will be monitored through routine trending.
Patient Sequence No: 1, Text Type: N, H10
[97016090]
On 09/09/2016, osteomed received information concerning a patient burn with the osteomed series iii straight drill that occurred on (b)(6) 2013. Prior to opening a complaint, a search was conducted to determine if this information had been previously reported and documented. Upon determining that this was osteomed's first awareness of this incident, this complaint investigation was initiated. During extraction of the patient's wisdom teeth, the drill overheated and caused a temperature injury to the patient's lower lip area. Dr. (b)(6) stopped the procedure at this time and finished the extraction with another device. Following this incident, dr. (b)(6) sent the drill to osteomed for repair and inspection. He used about 5 or 6 drills in rotation. Two devices were reported concerning this case: lot #: 032936 / serial (b)(4), lot #: 025479 / serial (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027754-2016-00008 |
| MDR Report Key | 7183616 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-01-11 |
| Date of Report | 2016-11-04 |
| Date of Event | 2013-05-23 |
| Date Mfgr Received | 2016-09-09 |
| Device Manufacturer Date | 2003-07-18 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 | 3 |
| Brand Name | OSTEOPOWER |
| Generic Name | SERIES III STRAIGHT DRILL |
| Product Code | KMW |
| Date Received | 2018-01-11 |
| Returned To Mfg | 2013-05-30 |
| Catalog Number | 450-0777 |
| Lot Number | 032936 |
| 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 |