MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2006-11-20 for MICROFRACTURE AWL 90 DEGREE 8204 manufactured by Conmed Linvatec.
[15033203]
It was reported that during use in an ankle arthroscopy, the tip of the awl broke off and was retrieved from the patient's joint. No additional treatment was needed.
Patient Sequence No: 1, Text Type: D, B5
[15313284]
Investigation results: to date, the device has not been returned to the manufacturer for evaluation. A follow-up report will be sent once an evaluation has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2006-00471 |
| MDR Report Key | 791094 |
| Report Source | 06,07 |
| Date Received | 2006-11-20 |
| Date of Report | 2006-10-27 |
| Date Mfgr Received | 2006-10-27 |
| Device Manufacturer Date | 1999-04-01 |
| Date Added to Maude | 2006-12-08 |
| 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 | MICROFRACTURE AWL 90 DEGREE |
| Generic Name | AWL |
| Product Code | LXI |
| Date Received | 2006-11-20 |
| Model Number | NA |
| Catalog Number | 8204 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 778738 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | * LARGO FL * US |
| Baseline Brand Name | MICROFRACTURE AWL 90 DEGREE |
| Baseline Generic Name | AWL |
| Baseline Model No | NA |
| Baseline Catalog No | 8204 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-20 |