MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2007-02-15 for BIO INSTABILITY DRILL GUIDE SERRATED C6172 manufactured by Conmed Linvatec.
[20622674]
It was reported that during use of this drill guide metal shavings were produced and not all of the shavings were retrieved. There was no reported injury or delay associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[20710127]
Investigational findings: the serrated drill guide was received for eval. During eval of the device, metal shavings were confirmed and galling was observed on the inner portion of the handle. Conmed linvatec will continue to monitor this product for failures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2007-00081 |
| MDR Report Key | 836313 |
| Report Source | 01,07,08 |
| Date Received | 2007-02-15 |
| Date of Report | 2007-01-17 |
| Date Mfgr Received | 2007-01-17 |
| Date Added to Maude | 2007-04-12 |
| 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 | 2007-02-15 |
| Returned To Mfg | 2006-01-17 |
| Model Number | NA |
| Catalog Number | C6172 |
| Lot Number | 0000618A |
| 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 | 823606 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | * LARGO FL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-15 |