MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-21 for PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS 1150001 manufactured by Medtronic Xomed Inc..
[36914040]
This device is used for therapeutic purposes. (b)(4). The device was returned and evaluated. Condition upon receipt: 1 un-sealed sample, part number 1150001, from lot number 0206940323 received; there was evidence of biological contaminants [based off of the reactivity with hydrogen peroxide]. Equipment used: microscope (zeiss stemi 2000c between 0, 65 to 5, 0 magnification settings), calipers (asset 1080-j). Evaluation: when compared to the assembly drawing: visually, the flex h/a was broke off of the titanium bell which would have resulted in the reported event. There was a residue consistent with adhesive at the juncture between the flex h/a and titanium bell which indicates it was manufactured per the drawing. When viewed under magnification, the head / shaft assembly was consistent with being modified / trimmed. The head shaft assembly measured 0. 156? And the configuration of the end was consistent with being cut. The titanium bell legs were bent inward and the h/a had scratches which indicates mishandling. The complaint was confirmed for the alleged malfunction [the shoe part broke]. Based on the product analysis findings the most likely cause of the event is consistent with operational context.
Patient Sequence No: 1, Text Type: N, H10
[36914041]
It was reported that "the shoe part of the prosthesis got broken during operation. The doctor used another new prosthesis to complete to surgery. " there was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2016-00017 |
| MDR Report Key | 5382956 |
| Date Received | 2016-01-21 |
| Date of Report | 2015-12-28 |
| Date of Event | 2015-12-24 |
| Date Mfgr Received | 2015-12-28 |
| Device Manufacturer Date | 2013-04-19 |
| Date Added to Maude | 2016-01-21 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHARLOTTE AYALA |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328372 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS |
| Generic Name | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
| Product Code | ETA |
| Date Received | 2016-01-21 |
| Returned To Mfg | 2016-01-19 |
| Model Number | 1150001 |
| Catalog Number | 1150001 |
| Lot Number | 0206940323 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-21 |