MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2007-01-11 for STERNUM SAW BLADE GUARD 00505900600 manufactured by Conmed Linvatec.
[570601]
It was reported that during use of this blade guard, it broke and fell into the surgical site. The broken portion was retrieved and an alternate blade guard was used. There was no pt injury nor delay related to this event.
Patient Sequence No: 1, Text Type: D, B5
[7941637]
Investigation findings: the product was received for eval and the reported problem was confirmed. A visual inspection of the device found that the shaft was broken. This damage can occur, as the shaft of the sternum guard can become damaged/bent overtime from handling/use. A review of product history for the past 2 years found no other reported events for this failure mode. Conmed linvatec will continue to monitor this product for failures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2006-00613 |
| MDR Report Key | 809100 |
| Report Source | 01,06,07 |
| Date Received | 2007-01-11 |
| Date of Report | 2006-12-14 |
| Date of Event | 2006-12-13 |
| Date Mfgr Received | 2006-12-14 |
| Device Manufacturer Date | 1998-04-01 |
| Date Added to Maude | 2007-01-29 |
| 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 | 0 |
| Manufacturer Contact | BEVERLY SCHANER |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995169 |
| Manufacturer G1 | CONMED LINVATEC |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| 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 | 3 |
| Brand Name | STERNUM SAW BLADE GUARD |
| Generic Name | BLADE GUARD |
| Product Code | KFK |
| Date Received | 2007-01-11 |
| Returned To Mfg | 2006-12-26 |
| Model Number | NA |
| Catalog Number | 00505900600 |
| Lot Number | P-04-98 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 796597 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | * LARGO FL * US |
| Baseline Brand Name | STERNUM SAW BLADE GUARD |
| Baseline Generic Name | BLADE GUARD |
| Baseline Model No | NA |
| Baseline Catalog No | 00505900600 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-11 |