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 2009-06-09 for BULLSEYE FEMORAL AIMER 5MM C8650 manufactured by Conmed Linvatec.
[1152846]
The customer reported that during use of this guide in an acl procedure, the distal tip broke off in the surgical site. The tip was successfully retrieved and the surgeon completed the procedure as intended. There was no patient injury or significant surgical delay related to this event.
Patient Sequence No: 1, Text Type: D, B5
[8311151]
To date, this device has not been received for evaluation. A follow-up report will be sent upon receipt of the device and completion of an evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2009-00075 |
| MDR Report Key | 1471571 |
| Report Source | 05,06,07 |
| Date Received | 2009-06-09 |
| Date of Report | 2009-05-14 |
| Date of Event | 2009-05-14 |
| Date Mfgr Received | 2009-05-14 |
| Date Added to Maude | 2010-06-02 |
| 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 | 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 | BULLSEYE FEMORAL AIMER 5MM |
| Generic Name | GUIDE, SURGICAL, INSTRUMENT |
| Product Code | LXI |
| Date Received | 2009-06-09 |
| Model Number | NA |
| Catalog Number | C8650 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-06-09 |