MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-26 for AMIS TABLE manufactured by Medacta Usa.
[24088816]
Patient Sequence No: 1, Text Type: N, H10
[24088817]
Rnfp connected the medacta hip bed attachment on the operating room bed because the rep had not arrived. The rep arrived, adjusted a few a straps then verified correct placement of the attachment. The patient was transferred from the stretcher to the operating room bed. It was noted the attachment was approximately 3 inches further south on the bed than it should be because the cassettes on the bed didn't allow for it to be slid up to the correct position. The patient was prepped, draped and surgical procedure started. During the procedure there were a few popping noises that alerted the staff that something was not right. Screws that hold the positioner to the bed clamps were breaking loose. Ortho team manager was notified. The surgery proceeded. After applying downward pressure to the femur, more popping noises were heard. The position was re-evaluated and deemed unsafe for the patient. A ring stand and standing stool were placed under the foot portion of the attachment. Peg board attachment holders were placed on the head portion of the positioner and this secured the positioner down to the bed. The procedure was completed. No harm to patient. Post-op inspection revealed that the attachment integrity was completely compromised. The brackets attaching the positioner to the bed clamps were broke and all of the screws that held the attachment to the plastic backing were pulled out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5031082 |
| MDR Report Key | 5031082 |
| Date Received | 2015-08-26 |
| Date of Report | 2015-08-05 |
| Date of Event | 2015-02-10 |
| Report Date | 2015-02-19 |
| Date Reported to FDA | 2015-02-19 |
| Date Reported to Mfgr | 2015-02-19 |
| Date Added to Maude | 2015-08-26 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | AMIS TABLE |
| Generic Name | TABLE, OPERATING-ROOM, MECHANICAL |
| Product Code | FWX |
| Date Received | 2015-08-26 |
| Returned To Mfg | 2015-02-22 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDACTA USA |
| Manufacturer Address | 1556 W. CARROLL AVE. CHICAGO IL 60607 US 60607 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-26 |