MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-02-21 for GIGLI SAW 12 INC 273510000 manufactured by Deputy Orthopaedics, Inc..
[215615]
When making a cut on a little child; the dr didn't get half way through the bone and observed the saw blade coming loose. Gigli saw broke and several pieces fell into the wound.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2001-00063 |
| MDR Report Key | 316729 |
| Report Source | 05 |
| Date Received | 2001-02-21 |
| Date of Report | 2001-02-21 |
| Date Facility Aware | 2001-01-22 |
| Report Date | 2001-02-21 |
| Date Mfgr Received | 2001-01-22 |
| Device Manufacturer Date | 2000-11-01 |
| Date Added to Maude | 2001-02-23 |
| 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 |
| Manufacturer Contact | HANS KUSSEROW, MGR |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 2193727416 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581098 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0988 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GIGLI SAW 12 INC |
| Generic Name | MANUAL ORTHOPAEDIC INSTRUMENT |
| Product Code | HSO |
| Date Received | 2001-02-21 |
| Model Number | NA |
| Catalog Number | 273510000 |
| Lot Number | U59AA4000 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 306268 |
| Manufacturer | DEPUTY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US |
| Baseline Brand Name | GIGLI SAW 12 IN |
| Baseline Generic Name | GIGLI SAW INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | 273510000 |
| Baseline ID | NA |
| Baseline Device Family | GIGLI SAW INSTRUMENT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-02-21 |