MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2006-11-13 for BIO INSTABILITY DRILL GUIDE SERRATED C6172 manufactured by Conmed Linvatec.
[564168]
The customer reported that during use of the drill guide in a shoulder arthroscopy, metal shavings were observed in the joint. It is not known if all metal shavings were retrieved. To date, the patient is doing fine and no additional treament is planned.
Patient Sequence No: 1, Text Type: D, B5
[8057722]
Investigation findings: the drill guide was received for evaluation. A visual examination of the device found burs at the distal end of the drill guide. A corrective action has been initiated by the vendor for this failure mode. Conmed linvatec will continue to monitor this product for failures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2006-00459 |
| MDR Report Key | 785889 |
| Report Source | 06,07 |
| Date Received | 2006-11-13 |
| Date of Report | 2006-10-20 |
| Date Mfgr Received | 2006-10-20 |
| Date Added to Maude | 2006-11-24 |
| 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 | BIO INSTABILITY DRILL GUIDE SERRATED |
| Generic Name | DRILL GUIDE |
| Product Code | LXI |
| Date Received | 2006-11-13 |
| Returned To Mfg | 2006-10-30 |
| Model Number | NA |
| Catalog Number | C6172 |
| Lot Number | NA |
| 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 | 773688 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | * LARGO FL * US |
| Baseline Brand Name | BIO INSTABILITY DRILL GUIDE SERRATED |
| Baseline Generic Name | DRILL GUIDE |
| Baseline Model No | NA |
| Baseline Catalog No | C6172 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-13 |