MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-05 for BONE CURETTE-REVERSE ANGLED 5.5MM X 8MM CD389.611 manufactured by Synthes Brandywine.
[24086948]
Patient initials: (b)(6). Patient information is unknown. Device is an instrument and is not implanted/explanted. 510k number is unknown. A review of the device history record was completed: three custom device parts were manufactured on 12july2005. One part was scrapped to meet the custom device request for a quantity of two. No non-conformities were generated during the manufacturing of this lot. The parts were checked for form, fit and functional operation and passed. All raw material used to manufacture this lot have been reviewed and no issues were observed. Review of the device history records showed that there were no issues during the manufacture of the product that may contribute to this complaint condition. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[24086949]
It was reported that the curette handle broke in half intra-operatively. It was reported that while a surgeon was performing a discectomy at l5-s1 on (b)(6) 2015, the curette handle broke in half. Pieces of the handle did not fall inside the wound. The surgeon had this curette custom made. A different curette was used to complete the surgery. There was no harm to the patient and no delay in surgery. This is report 1 of 1 for com-(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530088-2015-10531 |
| MDR Report Key | 4974236 |
| Date Received | 2015-08-05 |
| Date of Report | 2015-07-21 |
| Date of Event | 2015-07-21 |
| Date Mfgr Received | 2015-07-21 |
| Device Manufacturer Date | 2005-07-12 |
| Date Added to Maude | 2015-08-05 |
| 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 | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES BRANDYWINE |
| Manufacturer Street | 1303 GOSHEN PARKWAY |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BONE CURETTE-REVERSE ANGLED 5.5MM X 8MM |
| Generic Name | CURETTE |
| Product Code | HTF |
| Date Received | 2015-08-05 |
| Catalog Number | CD389.611 |
| Lot Number | 5007573 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES BRANDYWINE |
| Manufacturer Address | 1303 GOSHEN PARKWAY WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-05 |