MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-07 for BLACK OVAL-TOP TORP,HA, PP 140858 manufactured by Gyrus Acmi, Inc.
[144851494]
As part of our investigation, olympus followed up with the user facility to obtain additional information regarding the reported event but no information was obtained. The referenced device was returned to olympus for evaluation. A visual inspection of the received condition was performed on the device; the device was received opened in the original box and packing. The device was inspected under a microscope; foreign material noted, consistent that the device was in use. The evaluation confirmed the device was broken into two pieces. The exact cause of the reported event could not be conclusively determined. However, based on the physical evaluation, the operator's technique cannot be ruled out as a contributory factor. As a preventive measure, the instruction manual provides warning and cautions which state, as all prostheses are inherently delicate and some materials, such as hydroxylapatite, are brittle in nature, careful handling is essential to prevent damage during manipulation, trimming or sizing, and implantation/explantation. All trimming or sizing should be performed on a cutting block with only the shaft resting on the surface of the cutting block so as not to place excessive stress on the head and shaft interface. Inspect all packages for punctures or evidence of contamination prior to opening. The products will remain sterile in an undamaged, unopened package.
Patient Sequence No: 1, Text Type: N, H10
[144851495]
Olympus was informed that during an unspecified procedure, the doctor went to implant the device into the patient, but the device broke into two pieces. The "ball" portion came off the device prior to implantation. The procedure was not completed. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00809 |
| MDR Report Key | 8587169 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-07 |
| Date of Report | 2019-05-31 |
| Date of Event | 2019-04-09 |
| Date Mfgr Received | 2019-05-10 |
| Device Manufacturer Date | 2018-01-09 |
| Date Added to Maude | 2019-05-07 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLACK OVAL-TOP TORP,HA, PP |
| Generic Name | BLACK OVAL-TOP TORP |
| Product Code | ETA |
| Date Received | 2019-05-07 |
| Returned To Mfg | 2019-04-24 |
| Model Number | 140858 |
| Lot Number | MH694292 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-07 |