MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-17 for INNOMED PERIOSTEAL ELEVATOR 3450 manufactured by Innomed Orthopedic Instruments / Innomed, Inc..
[133829697]
Patient in surgery for total hip arthroplasty. A periosteal elevator (chisel type product) #3450, being utilized by the surgeon broke. All pieces retrieved. No harm to the patient. Referred to manager of central sterile to address.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083220 |
| MDR Report Key | 8260840 |
| Date Received | 2019-01-17 |
| Date of Report | 2019-01-16 |
| Date of Event | 2019-01-15 |
| Date Added to Maude | 2019-01-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 0 |
| Brand Name | INNOMED PERIOSTEAL ELEVATOR |
| Generic Name | CHISEL |
| Product Code | EML |
| Date Received | 2019-01-17 |
| Model Number | 3450 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INNOMED ORTHOPEDIC INSTRUMENTS / INNOMED, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-17 |