MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-12-28 for BRUNS CURETTE OVAL ANG CUP SZ 0000 9IN NL6760 manufactured by Carefusion.
[2499149]
Broken the curette tip broke off during total right knee arthroplasty.? The tip of the curette sucked into suction container.? There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
[9616451]
(b)(4). The customer has indicated that the complaint sample cannot be returned to carefusion. Since the instrument is not available, an evaluation could not be performed.
Patient Sequence No: 1, Text Type: N, H10
[9739780]
(b)(4). The customer indicated that they cannot release the instrument for evaluation. However, they will allow a representative to visit on-site and inspect the instrument.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2011-00020 |
| MDR Report Key | 2390920 |
| Report Source | 00 |
| Date Received | 2011-12-28 |
| Date of Report | 2011-11-29 |
| Date of Event | 2011-11-11 |
| Date Mfgr Received | 2011-11-29 |
| Date Added to Maude | 2012-07-26 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8474737294 |
| Manufacturer G1 | CAREFUSION 2200, INC |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | WAUKEGAN 60085785 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60085 7853 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRUNS CURETTE OVAL ANG CUP SZ 0000 9IN |
| Generic Name | CURETTE, SURGICAL, GENERAL USE |
| Product Code | FZS |
| Date Received | 2011-12-28 |
| Model Number | NL6760 |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 1500 WAUKEGAN ROAD MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-28 |