MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-05-15 for ACUFEX ENDOSCOPIC FEMORAL GUIDE 2.4.MM 014456 manufactured by Smith & Nephew Endoscopy, Inc..
[59524]
Device tip was reported to have broken in surgery. Broken piece was retrieved without any surgicl delay. No pt injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-1997-00036 |
| MDR Report Key | 92363 |
| Report Source | 05,06 |
| Date Received | 1997-05-15 |
| Date of Event | 1997-04-18 |
| Date Facility Aware | 1997-04-18 |
| Date Mfgr Received | 1997-04-18 |
| Device Manufacturer Date | 1993-06-01 |
| Date Added to Maude | 1997-05-23 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUFEX ENDOSCOPIC FEMORAL GUIDE 2.4.MM |
| Generic Name | DRILL GUIDE |
| Product Code | HXY |
| Date Received | 1997-05-15 |
| Returned To Mfg | 1997-04-22 |
| Model Number | NA |
| Catalog Number | 014456 |
| Lot Number | 593 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 91230 |
| Manufacturer | SMITH & NEPHEW ENDOSCOPY, INC. |
| Manufacturer Address | 130 FORBES BLVD. MANSFIELD MA 02048 US |
| Baseline Brand Name | ACUFEX ENDOSCOPIC FEMORAL GUIDE 2.4.MM |
| Baseline Generic Name | DRILL GUIDE |
| Baseline Model No | NA |
| Baseline Catalog No | 014456 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-05-15 |