MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-20 for MATRIXMANDIBLE SMALL PLATE CUTTER 03.503.079 manufactured by Wrights Lane Synthes Usa Products Llc.
[118106746]
Device is an instrument and is not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. Device history record review has been requested. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[118106747]
It was reported that when cleaning the matrixmandible plate cutters at the sterile processing department on (b)(6) 2018, the tension band broke off of the cutter. There was no procedure nor patient involvement. This report is for a matrixmandible small plate cutter. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-53376 |
| MDR Report Key | 7797042 |
| Date Received | 2018-08-20 |
| Date of Report | 2018-10-16 |
| Date of Event | 2018-08-03 |
| Date Mfgr Received | 2018-10-05 |
| Device Manufacturer Date | 2007-05-15 |
| Date Added to Maude | 2018-08-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MATRIXMANDIBLE SMALL PLATE CUTTER |
| Generic Name | INSTR,BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2018-08-20 |
| Returned To Mfg | 2018-10-05 |
| Model Number | 03.503.079 |
| Catalog Number | 03.503.079 |
| Lot Number | A7QA13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-20 |