MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-05-11 for SAW & MICRO SAGISAW 2316 manufactured by Zimmer, Inc..
[14686]
During procedure (podiatric) small metal fragment dropped from saw into open wound. Instrument checked by sterile supply and was noted to have been decontaminated prior to surgery. Equipment returned to mfr for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 22406 |
| MDR Report Key | 22406 |
| Date Received | 1995-05-11 |
| Date of Report | 1995-05-11 |
| Date of Event | 1995-05-01 |
| Date Facility Aware | 1995-05-01 |
| Report Date | 1995-05-11 |
| Date Reported to FDA | 1995-05-11 |
| Date Added to Maude | 1995-06-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAW & MICRO SAGISAW |
| Generic Name | SAW & MICRO SAGISAW |
| Product Code | GDR |
| Date Received | 1995-05-11 |
| Returned To Mfg | 1995-05-02 |
| Model Number | 2316 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 22557 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | PT. WASHINGTON NY 11050 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-05-11 |