MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-12-21 for RECTANGULAR BONE CURETTE 389.124 manufactured by Synthes Gmbh.
[3110072]
Posterior lumbar fusion l5-s1, during discectomy top of box curette broke off into the surgical site. All pieces were retrieved.
Patient Sequence No: 1, Text Type: D, B5
[10388391]
This device was for treatment not for diagnosis. Investigation could not be completed, no conclusion could be drawn as no device was returned. The device history record is not available for review as the device is over twelve years old.
Patient Sequence No: 1, Text Type: N, H10
[10444121]
Device used for treatment and not diagnosis. This failure occurred due to bending stress beyond the ultimate strength of the material. If the distal tip were completely constrained, 22 pounds applied to the handle would potentially break the curette. Considering these boundary conditions are nearly clinically impossible, the strength for this instrument under normal use is acceptable. Released in 1999, this is a mature rectangular bone curette. The drawings call out appropriate materials and dimensions for robust curette design. An exact cause for this complaint is not possible due to unknown clinical boundary conditions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2012-01641 |
| MDR Report Key | 2883355 |
| Report Source | 05,07 |
| Date Received | 2012-12-21 |
| Date of Report | 2012-11-26 |
| Date of Event | 2012-11-26 |
| Date Mfgr Received | 2012-12-21 |
| Date Added to Maude | 2013-03-25 |
| 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 | R MILLER |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES GMBH |
| Manufacturer Street | EIMATTSTRASSE 3 CH-4436 |
| Manufacturer City | OBERDORF |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RECTANGULAR BONE CURETTE |
| Generic Name | BONE CURETTE |
| Product Code | FZS |
| Date Received | 2012-12-21 |
| Returned To Mfg | 2012-12-21 |
| Catalog Number | 389.124 |
| Lot Number | A7JA22 |
| 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 GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 CH-4436 OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-21 |