MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-12-12 for ORACLE BAYONETED RING CURETTE 6MM TIP WIDTH 03.809.873 manufactured by Synthes Tuttlingen.
[5134104]
It was reported the head of the device broke during surgery after about eight months of usage. The procedure was extended approximately 10 minutes due to the event. No other information is available this is report 1 of 1 for com- (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[5165933]
Device report from synthes (b)(4) reports an event in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[12646728]
Additional narrative: a manufacturing evaluation was completed: the handle shows signs of usage and head is indeed broken as reported. The front part is even bent. Based on examination of the article it is likely that either that article came into contact with a hard surface and the head broke off or excess force may have been used when removing disc material during the discectomy step of the surgical procedure. A full review of the device history record was conducted for this lot number and this article was manufactured to specification in september 2009. We also conducted a review of our complaints data base and this is the only incident of this description on our system. No actual product fault could be found. 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
[12663984]
Device is an instrument and is not implanted/explanted. Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. The raw material which was delivered as lot #00047652 is corresponding to the specifications. The hardness was measured at the time of the manufacturing between 47-49 hrc and was found to be good. No nonconformance reports were generated during production. The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system. 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
| Report Number | 9680938-2014-10095 |
| MDR Report Key | 4324374 |
| Report Source | 01,05,07 |
| Date Received | 2014-12-12 |
| Date of Report | 2014-11-14 |
| Date of Event | 2014-11-14 |
| Date Mfgr Received | 2014-12-18 |
| Device Manufacturer Date | 2009-09-21 |
| Date Added to Maude | 2014-12-24 |
| 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 | 0 |
| Event Location | 0 |
| 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 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 | 3 |
| Brand Name | ORACLE BAYONETED RING CURETTE 6MM TIP WIDTH |
| Generic Name | CURETTE |
| Product Code | HTF |
| Date Received | 2014-12-12 |
| Returned To Mfg | 2014-12-09 |
| Catalog Number | 03.809.873 |
| Lot Number | T940599 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES TUTTLINGEN |
| Manufacturer Address | UNTER HASSLEN 5 TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-12 |