MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-10-01 for FREER SEPTUM ELEVATOR 65-6620 manufactured by Codman & Shurtleff, Inc..
[1244542]
Customer reports that "during a right foot surgery (bone graft) the instrument broke in two pieces causing laceration. Pt required a couple of sutures and was okay after surgery. No significant delay in surgery verified". Additional info from the user facility report: in 2009, during basketball practice, the pt refractured the lateral and interior cortex of the right foot. During the right metatarsal bone graft procedure, the freer elevator broke into two pieces. The instrument slipped off the bone and caused two small lacerations to the skin on the right lateral ankle (1/8 - 1/4 inch in size). The lacerations were sutured, and the pt was taken to the recovery room in good condition.
Patient Sequence No: 1, Text Type: D, B5
[8283957]
Upon completion of the investigation, it was noted that this complaint has been confirmed. One side of the shaft was broken off approximately 3/4 inch from the tip. The fractured surface of the device revealed evidence of corrosion. This type of fracture/breakage typically occurs due to use/wear over a prolonged period of time (this instrument is approximately 9 years old and out of warranty). It could also occur when there has been a small crack in the material brought about by either overly aggressive use/abuse of the instrument or through a manufacturing error in the original setting or bending of the instrument. Subsequent corrosion and stressing of the cracked site appears to have brought about the failure noted. It is not possible to determine how the original crack was formed. This appears to be occurring within expected limits for this type of problem. Based on the results of this investigation, no further action is needed as a result. 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. Additional info from the user facility report: pt: male. Codman freer elevator, device available for eval: date user facility or importer became aware of event: 2009. Date of this report: 09/23/09. Report sent to fda? No. Report sent to mfr? Yes. 09/23/09.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2009-00258 |
| MDR Report Key | 1507852 |
| Report Source | 05 |
| Date Received | 2009-10-01 |
| Date of Report | 2009-09-23 |
| Date of Event | 2009-09-16 |
| Date Reported to Mfgr | 2009-09-29 |
| Date Mfgr Received | 2009-09-21 |
| Device Manufacturer Date | 2000-07-01 |
| Date Added to Maude | 2009-10-20 |
| 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 | 3 |
| 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 | 2009-10-01 |
| Returned To Mfg | 2009-09-28 |
| Model Number | NA |
| Catalog Number | 65-6620 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| 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. Other; 2. Required No Informationntervention | 2009-10-01 |