MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-04-23 for FREER SEPTUM ELEVATOR 65-6620 manufactured by Codman & Shurtleff, Inc..
[20200850]
Customer reported that the freer elevator broke in the pt. Customer called and explained that the surgeon needed to make the incision longer and needed to use a c-arm to remove the device. The surgery was not significantly delayed and there was no harm to the pt.
Patient Sequence No: 1, Text Type: D, B5
[20397696]
Upon completion of the investigation, it was noted that this complaint has been confirmed. A visual examination revealed that one side of the shaft is broken at approx 1/2 inch from the tip. The fractured surface revealed evidence of corrosion on at least part of the fracture. This type of fracture/breakage typically occurs due to use/wear over a prolonged period of time (this instrument is approx 18 years old). It may also occur when there has been a small crack in the material bought about by either overly aggressive use/abuse of the instrument or through a mfg error in the original setting or bending of the instrument. It is not possible to determine how the original crack was formed. Based on the results of this investigation no further action is required. This is the first complaint of this type for this product, therefore; it is considered to be an isolated incident. 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 | 1226348-2008-00101 |
| MDR Report Key | 1033192 |
| Report Source | 05 |
| Date Received | 2008-04-23 |
| Date Mfgr Received | 2008-03-26 |
| Date Added to Maude | 2009-02-23 |
| 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 | FREER SEPTUM ELEVATOR |
| Generic Name | ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GEG |
| Date Received | 2008-04-23 |
| Returned To Mfg | 2008-03-27 |
| Model Number | NA |
| Catalog Number | 65-6620 |
| Lot Number | 915 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2008-04-23 |