MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2006-11-08 for GRAFIX FEMORAL TUNNEL NOTCHER C8106 manufactured by Conmed Linvatec.
[572766]
It was reported that during use in an acl surgery, the surgeon had difficulty removing the tunnel notcher and the tip of the instrument broke off inside the pt's knee. The surgeon looked for the tip to retrieve it, and shortly after, it was found on the floor. It is believed that irrigation flushed the tip out of the joint. There was no report of injury or surgical delay.
Patient Sequence No: 1, Text Type: D, B5
[7987198]
Investigation results: the instrument and broken tip were rec'd for evaluation. The customer's reported problem was verified. A material hardness check was performed on the device and found to meet specifications. The cause for the breakage was unable to be determined. A review of conmed linvatec records for this product found no other reported events for this failure mode. This product will continue to be monitored for failures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2006-00436 |
| MDR Report Key | 787672 |
| Report Source | 06,07 |
| Date Received | 2006-11-08 |
| Date of Report | 2006-10-11 |
| Date of Event | 2006-10-11 |
| Date Mfgr Received | 2006-10-11 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2006-11-30 |
| 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 | GRAFIX FEMORAL TUNNEL NOTCHER |
| Generic Name | FEMORAL TUNNEL NOTCHER |
| Product Code | MZY |
| Date Received | 2006-11-08 |
| Returned To Mfg | 2006-10-17 |
| Model Number | NA |
| Catalog Number | C8106 |
| Lot Number | 00835151 |
| 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 | 775437 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | * LARGO FL * US |
| Baseline Brand Name | GRAFIX FEMORAL TUNNEL NOTCHER |
| Baseline Generic Name | FEMORAL TUNNEL NOTCHER |
| Baseline Model No | NA |
| Baseline Catalog No | C8106 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-08 |