MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-24 for PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS 1150001 manufactured by Medtronic Xomed Inc..
[177248105]
The product is shipped in a ridged capsule which protects the device during shipping. There were no signs that the device was closed in the lid of the capsule. Visually, the flex h/a had become detached from the titanium bell which would have resulted in the reported event. Adhesive is required to bind the two components together and when viewed under magnification, a residue consistent with adhesive was present in the mounting area which likely indicates it was assembled properly. The portion that had become detached was installed on the shaft indicating handling. The flex h/a was removed from the shaft for further analysis. The overall length of the head shaft assembly should be approximately 0. 400? And the actual measurement was 0. 072?. The shaft configuration is consistent with being cut off. The cam head was bent and contained tool marks. The flex h/a is a porous material measuring approximately 0. 045? In diameter which makes it vulnerable to mishandling. There was no allegation of a defect prior to handling. There was no evidence of improper manufacturing and therefore has been ruled out as a likely cause. The information most likely indicates the device was modified and the damage occurred while handling. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[177248106]
A healthcare provider (hcp) reported that during a procedure for a cholesteatoma resection, artificial ossicular implantation and tympanoplasty, the artificial ossicular implant was broken during the tympanic portion of the surgery. The surgeon removed the broken device and? Switched to the autologous ossicle for hearing reconstruction and completed the operation.? The patient was alive with no injury. On follow up, it was confirmed there was no procedure delay. There was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2020-00056 |
| MDR Report Key | 9625835 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-24 |
| Date of Event | 2019-12-30 |
| Date Mfgr Received | 2019-12-30 |
| Device Manufacturer Date | 2017-11-06 |
| Date Added to Maude | 2020-01-24 |
| 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 | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328353 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| 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 | 3 |
| Brand Name | PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS |
| Generic Name | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
| Product Code | ETA |
| Date Received | 2020-01-24 |
| Returned To Mfg | 2020-01-13 |
| Model Number | 1150001 |
| Catalog Number | 1150001 |
| Lot Number | 0214341098 |
| 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 | 2020-01-24 |