MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-06-21 for CASPAR CURETTE SQ-TIP 5MM220MM FK835R manufactured by Aesculap Ag And Co. Kg.
[18530111]
Country of complaint: (b)(6). After placing prospace in one side of the intervertebral space, the surgeon continued to remove cartilaginous tissue in the other side of the intervertebral space. At this time the blade broke and the broken tip was trapped inside the space. It took 5 minutes to remove the broken tip.
Patient Sequence No: 1, Text Type: D, B5
[18700624]
Evaluation: instrument manufactured in 2002. Material and hardness (56 hrc) correspond to the specifications. There are no hints for material or product failures. The surface of the breakage shows signs of corrosion. The instrument was cracked during a previous surgery. This crack resulted in a reduced firmness of the affected part, so that even with normal force, a breakage is possible. The root cause of the breakage is the incipient crack which was caused by a mechanical overload situation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2013-00061 |
| MDR Report Key | 3196052 |
| Report Source | 01,07 |
| Date Received | 2013-06-21 |
| Date of Report | 2013-06-21 |
| Date of Event | 2013-04-25 |
| Date Mfgr Received | 2013-05-13 |
| Device Manufacturer Date | 2002-01-01 |
| Date Added to Maude | 2013-09-16 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELLE LINK |
| Manufacturer Street | 615 LAMBERT POINTE DR. |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515938 |
| Manufacturer G1 | AESCULAP AG AND CO. KG |
| Manufacturer Street | P.O. BOX 40 |
| Manufacturer City | TUTTLINGEN 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CASPAR CURETTE SQ-TIP 5MM220MM |
| Product Code | FZS |
| Date Received | 2013-06-21 |
| Returned To Mfg | 2013-05-24 |
| Model Number | FK835R |
| Catalog Number | FK835R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG AND CO. KG |
| Manufacturer Address | TUTTLINGEN DE 78532 US 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-06-21 |