MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-06 for ALVARADO KNEE SUPPORT AND STABILIZING PLATE: ALVARADO LEG HOLDER 00132000000 manufactured by Zimmer Inc..
[126639152]
Issue with alvarado knee holder - previous cleaning instructions did not include loosening of slotted hook screws on base plate. Learned through sterile processing blog that because of this there can be retained bio-burden trapped under the slotted hooks. In 2017, updated ifu put out by mfr including direction to loosen screws prior to cleaning. There is no automated washer or detergent validation which leads to cleaning efficacy concerns. Upon examination of equipment base plates and slotted hook areas debris and bio-burden have been visualized in screws and slotted hook areas. Based on examination, mfr was contacted and is in process of providing replacement equipment. Going forward, will be following updated ifu for cleaning and have asked the mfr to validate automated washer and detergent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081120 |
| MDR Report Key | 8046213 |
| Date Received | 2018-11-06 |
| Date of Report | 2018-11-02 |
| Date of Event | 2018-10-22 |
| Date Added to Maude | 2018-11-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ALVARADO KNEE SUPPORT AND STABILIZING PLATE: ALVARADO LEG HOLDER |
| Generic Name | ALVARADO KNEE HOLDER |
| Product Code | FWZ |
| Date Received | 2018-11-06 |
| Model Number | 00132000000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER INC. |
| Manufacturer Address | WARSAW IN 46580 US 46580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-06 |