MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-16 for TREPHINE DRILL #TREPH-4 manufactured by Salvin Dental Specialties.
[54924781]
The submission delay for the initial medwatch is due to account registration issues. Device was used for treatment, not diagnosis. A lot number was not reported and udi is unavailable. The subject device has been received and evaluated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Product investigation summary: no visual defects other than the fractured columns. The failure occurred at the shank to trephine transition areas (2 small cross-sectional members (columns) that support the circular cutting burs. Based on the fracture orientation a torsion fatigue failure can be concluded. The failure is consistent with excessive off axis force to the distal tip. Preventative action was implemented in 2015, after the manufacturing of the subject device, to increase the strength of the device. The cross-sectional area at the fracture location has been increased.
Patient Sequence No: 1, Text Type: N, H10
[54924782]
The doctor was using the trephine burr connected to an electric hand piece to remove a lower anterior implant when the trephine separated from the instrument shank. The shank remained connected to the hand piece and then cut the patient's interior lip which required suturing. The separated trephine and the shank were retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003005156-2016-00001 |
| MDR Report Key | 5955840 |
| Date Received | 2016-09-16 |
| Date of Report | 2016-07-29 |
| Date of Event | 2016-06-20 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2016-09-16 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TREPHINE DRILL |
| Generic Name | TREPHINE |
| Product Code | HWK |
| Date Received | 2016-09-16 |
| Returned To Mfg | 2016-06-28 |
| Catalog Number | #TREPH-4 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SALVIN DENTAL SPECIALTIES |
| Manufacturer Address | 3450 LATROBE DRIVE CHARLOTTE NC 28211 US 28211 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-16 |