MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2005-08-05 for HALL STERNUM SAW (PNEUMATIC) 00505900500 manufactured by Linvatec Corporation.
[435127]
The user reported difficulty in inserting saw blades into their sternum saws and in 07/05, the sales representative was at the facility performing this product training. The user reported that they were concerned with any type of delay in inserting a saw blade into the sternum saw. They then reported that a pt had expired and that any type of delay in assembling the saw blade and sternum saw would be unacceptable. The reporter confirmed to the sales representative and linvatec that this sternum saw was not used on the pt. The pt died from a ruptured aorta. Their deathe was not associated with the device. Linvatec requested the sternum saw to be returned for investigation, but repeated attempts to obtain the device have gone unanswered. They did report that the sternum saw has been sent to risk management. They also reported that they utilize a 3rd party repair facility, but attempts by linvatec regulatory to obtain the name of this facility were not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2005-00156 |
| MDR Report Key | 624817 |
| Report Source | 05,06,07 |
| Date Received | 2005-08-05 |
| Date of Report | 2005-07-08 |
| Date of Event | 2005-05-20 |
| Date Mfgr Received | 2005-07-08 |
| Date Added to Maude | 2005-08-09 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ROGER MURPHY |
| Manufacturer Street | 11311 CONCEPT BLVD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995205 |
| Manufacturer G1 | LINVATEC CORPORATION |
| 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 | HALL STERNUM SAW (PNEUMATIC) |
| Generic Name | STERNUM SAW PNEUMATIC |
| Product Code | KFK |
| Date Received | 2005-08-05 |
| Model Number | NA |
| Catalog Number | 00505900500 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 614445 |
| Manufacturer | LINVATEC CORPORATION |
| Manufacturer Address | * LARGO FL * US |
| Baseline Brand Name | HALL STERNUM SAW (PNEUMATIC) |
| Baseline Generic Name | STERNUM SAW PNEUMATIC |
| Baseline Model No | NA |
| Baseline Catalog No | 00505900500 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K801737 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2005-08-05 |