MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1997-02-05 for ACUFEX REAR ENTRY AIMER - RIGHT 013642 manufactured by Smith & Nephew, Inc. Endoscopy Div..
[43404]
Device was reported to break in acl reconstruction surgery. Broken piece was retrieved and no pt injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-1997-00003 |
| MDR Report Key | 68497 |
| Report Source | 05,06,07 |
| Date Received | 1997-02-05 |
| Date Mfgr Received | 1997-01-09 |
| Device Manufacturer Date | 1991-08-01 |
| Date Added to Maude | 1997-02-18 |
| 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 - RIGHT |
| Generic Name | DRILL GUIDE |
| Product Code | HXY |
| Date Received | 1997-02-05 |
| Returned To Mfg | 1997-01-09 |
| Model Number | NA |
| Catalog Number | 013642 |
| Lot Number | 991 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5.5 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 68478 |
| Manufacturer | SMITH & NEPHEW, INC. ENDOSCOPY DIV. |
| Manufacturer Address | 130 FORBES BLVD MANSFIELD MA 02048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-02-05 |