MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-04 for PERIOSTEAL ELEVATOR-CURVED 3450 manufactured by Innomed, Inc..
[137950940]
Patient Sequence No: 1, Text Type: N, H10
[137950941]
Report mw5083220 was received at innomed from the center for devices and radiological health on 2/4/2019 with following event description documented: 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 patient. Referred to manager of central sterile to address. Response: innomed contacted the initial reporter on the day the device was received and requested to have it returned for an evaluation. Return authorization number (b)(4) and sterilization confirmation form were forwarded on the above referenced date. The internal complaints database was surveyed for the above described issue. Upon receipt at innomed on 2/11/2019, the device was inspected and evaluated by quality control. The following results were documented: performed evaluation of failure and found damage to the working end that indicates the instrument was used in a lever motion on a hard object. See attached pictures. The tip in three places is rolled downward indicating a force was used that exceeded the force required to elevate periosteal tissue. This instrument was designed to elevate the periosteal tissue and should not be used to chisel or elevate hard objects. Based on evaluation findings, it was determined that the failure was not a result of design, material, or production failure. Misuse appears to be the root cause of the failure. No other damage was noted to instrument. The device has been on the market for since 2004, and this is the first complaint received. Innomed's capa log was also surveyed for the above described issue, and no entries were found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1833053-2019-00001 |
| MDR Report Key | 8387106 |
| Date Received | 2019-03-04 |
| Date of Report | 2019-02-13 |
| Date of Event | 2019-01-15 |
| Report Date | 2019-02-13 |
| Date Reported to FDA | 2019-02-13 |
| Date Reported to Mfgr | 2019-02-04 |
| Date Added to Maude | 2019-03-04 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Brand Name | PERIOSTEAL ELEVATOR-CURVED |
| Generic Name | TISSUE ELEVATOR |
| Product Code | HTE |
| Date Received | 2019-03-04 |
| Returned To Mfg | 2019-02-11 |
| Model Number | 3450 |
| Catalog Number | 3450 |
| Lot Number | 0817MT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 18 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INNOMED, INC. |
| Manufacturer Address | 103 ESTUS DRIVE SAVANNAH, GA GA 31404 US 31404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-04 |