MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-13 for COD CURETTE, BRUNS 0, CUP 3.7MM 32-3473 manufactured by Codman & Shurtleff, Inc..
[21639935]
Medwatch report explained that the #0 curette broke off in pt. Broken piece was removed. Incision has to be enlarged because it broke.
Patient Sequence No: 1, Text Type: D, B5
[21870858]
Upon completion of the investigation it was noted that the shaft is broken 3/4 of an inch from the distal end. This type of breakage typically occurs when there has been a small crack in the material. It was also noted that there was evidence of corrosion on at least part of the fractured surface. The tip is dull, which suggests excessive use over a prolonged period of time. This instrument is more than 5 years old. It is likely that atypical force was applied to the instrument to compensate for the dull cutting surfaces and resulted in breakage. This however could not be confirmed. It is not possible to determine how the original crack may have formed. This is the first complaint of this type for this product code, therefore, it is considered to be an isolated incident. Based on the results of this investigation no further action is required. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2011-00215 |
| MDR Report Key | 2135042 |
| Report Source | 05,06 |
| Date Received | 2011-06-13 |
| Date of Event | 2011-05-04 |
| Date Reported to Mfgr | 2011-06-08 |
| Date Mfgr Received | 2011-05-17 |
| Date Added to Maude | 2011-06-23 |
| 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 | MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Manufacturer G1 | CODMAN & SHURTLEFF, INC. |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COD CURETTE, BRUNS 0, CUP 3.7MM |
| Generic Name | INSTRUMENTS |
| Product Code | FZS |
| Date Received | 2011-06-13 |
| Returned To Mfg | 2011-05-20 |
| Model Number | NA |
| Catalog Number | 32-3473 |
| Lot Number | 056 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-06-13 |