MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-03-19 for ACUFEX REAR ENTRY AIMER-LEFT 013643 manufactured by Smith & Nephew, Inc. Endoscopy Div..
[134265]
Tip of instrument broke off while in use in surgery. Contact stated piece was retrieved without injury or complication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-1998-00010 |
| MDR Report Key | 158842 |
| Report Source | 05,06 |
| Date Received | 1998-03-19 |
| Date of Event | 1998-02-18 |
| Date Facility Aware | 1998-02-18 |
| Date Mfgr Received | 1998-02-19 |
| Device Manufacturer Date | 1990-04-01 |
| Date Added to Maude | 1998-03-26 |
| 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 REAR ENTRY AIMER-LEFT |
| Generic Name | DRILL GUIDE |
| Product Code | HXY |
| Date Received | 1998-03-19 |
| Returned To Mfg | 1998-02-24 |
| Model Number | NA |
| Catalog Number | 013643 |
| Lot Number | 590 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 8 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 154713 |
| Manufacturer | SMITH & NEPHEW, INC. ENDOSCOPY DIV. |
| Manufacturer Address | 130 FORBES BLVD. MANSFIELD MA 02048 US |
| Baseline Brand Name | ACUFEX REAR ENTRY AIMER-LEFT |
| Baseline Generic Name | DRILL GUIDE |
| Baseline Model No | NA |
| Baseline Catalog No | 013643 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-03-19 |