MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-10 for STERNUM SAW HANDPIECE 00505900500 manufactured by Conmed Corporation.
[113913180]
It was reported by the conmed representative that 00505900500, sternum saw handpiece continued to run after use. There was no patient/user injury or surgical delay with this reported issue and the procedure was completed as planned. The evaluation found that the roller caused the device to run without trigger activation. Parts were replaced as needed and preventative maintenance was performed. The service history was reviewed and no other complaints were found. A device history review was not done since the device has been in the field for more then 12 months. Per the instructions for use, the user is advised the following; cautions: handle all equipment carefully. Should a handpiece or attachment be dropped or damaged in any way, return it immediately for service. Continually check all parts of the instrument or its attachments for overheating. If overheating is noticed, discontinue use and return the equipment for service. Warnings: prior to each use, perform the following: a. Inspect all equipment for proper operation. B. Ensure all attachments, accessories, and hoses are correctly and completely attached to the handpiece. C. Inspect pneumatic hoses for signs of wear or damage prior to use. Discontinue use and replace immediately if any signs of wear or damage are detected.
Patient Sequence No: 1, Text Type: N, H10
[113913181]
It was reported by the conmed representative that 00505900500, sternum saw handpiece continued to run after use. There was no patient/user injury or surgical delay with this reported issue and the procedure was completed as planned. This report is being raised on the basis of a device malfunction with potential for injury with recurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2018-00105 |
| MDR Report Key | 7674841 |
| Date Received | 2018-07-10 |
| Date of Report | 2018-07-10 |
| Date of Event | 2018-06-20 |
| Date Mfgr Received | 2018-06-20 |
| Device Manufacturer Date | 2010-09-17 |
| Date Added to Maude | 2018-07-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MELANIE HANSEN |
| Manufacturer Street | 11311 CONCEPT BOULEVARD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995209 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 11311 CONCEPT BOULEVARD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STERNUM SAW HANDPIECE |
| Generic Name | PNEUMATIC SURGICAL SAW |
| Product Code | KFK |
| Date Received | 2018-07-10 |
| Returned To Mfg | 2018-06-27 |
| Catalog Number | 00505900500 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 11311 CONCEPT BOULEVARD LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-10 |