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 2009-09-03 for BULLSEYE FEMORAL AIMER 6MM C8660 manufactured by Conmed Linvatec.
[1241345]
The user reported that during use of this guide for an acl procedure, the tip broke off in the surgical site. The tip was retrieved and the surgeon completed the procedure using another femoral guide. There was no pt injury or significant surgical delay related to this event.
Patient Sequence No: 1, Text Type: D, B5
[8290643]
Conmed linvatec received this device for eval. An investigation of this failure remains in process. A f/u report will be sent upon completion of the investigation. The info for use (ifu) provides the following precautions: inspect instrument prior to use to ensure it is in good physical condition and functions properly. There should be no loose, broken or misaligned parts. Exercise care in the use of the device to minimize side or bending loads. Do not use excessive force on instruments to avoid damage or breakage during use. Inspect instrument after use to ensure it has not been damaged.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2009-00129 |
| MDR Report Key | 1497516 |
| Report Source | 01,06,07 |
| Date Received | 2009-09-03 |
| Date of Report | 2009-06-26 |
| Date of Event | 2009-06-26 |
| Date Mfgr Received | 2009-06-26 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2010-06-22 |
| 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 6MM |
| Generic Name | GUIDE, SURGICAL, INSTRUMENT |
| Product Code | LXI |
| Date Received | 2009-09-03 |
| Returned To Mfg | 2009-09-02 |
| Model Number | NA |
| Catalog Number | C8660 |
| Lot Number | 10516A |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2009-09-03 |