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 2016-11-03 for PROSTHESIS - FLEX HA 0528 manufactured by Medtronic Xomed Inc..
[59066702]
Product evaluation: analysis results not available; the device was not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[59066703]
It was reported that? During ossiculoplasty for mixed hearing loss, the prosthesis broke in two, between the head and the body of the device; the metallic part detached from the plastic part during implantation. The? Two parts? Were inside the patient? S ear canal when the surgeon retrieved them but there was no consequence for the patient; another prosthesis was used to complete the procedure.? There was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
[60915943]
Date of this report: 10/10/2016. Is the device available for evaluation? Yes. Received: 11/02/2016. Date manufacturer received: 11/16/2016. Product evaluation: for analysis, 1 un-sealed sample, part number 0528, from lot number 0210564932 was received; there was evidence of biological contaminants [based off of the reactivity with hydrogen peroxide]. The product is shipped in a ridged capsule which likely indicates the device was not damaged in shipping. When compared to the assembly drawing: visually, the flex h. A. Was detached from the titanium link which would have resulted in the reported event. When viewed under magnification, one side of the flex h. A. Was consistent with breakage while the other side was consistent with being trimmed which likely indicates modification. The detached flex h. A. Actual measurement was 0. 08? Long and when compared to the link drawing and the assembly drawing, the detached portion? Should? Have measured approximately 0. 138? Which is in support of the likely modification. The titanium link where the detached piece mounts showed a residue consistent with adhesive which likely indicates it was assembled properly. The approximate wall thickness is 0. 011? In the area of the breakage which makes it susceptible to any sort of mishandling. There was no evidence of improper manufacturing and therefore has been ruled out as a likely cause. The information most likely indicates the damage occurred as a result of mishandling and / or modification of the device. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[102578473]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2016-00375 |
| MDR Report Key | 6075289 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-11-03 |
| Date of Report | 2016-10-10 |
| Date of Event | 2016-09-14 |
| Date Mfgr Received | 2016-11-16 |
| Device Manufacturer Date | 2015-12-14 |
| Date Added to Maude | 2016-11-03 |
| 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 | MICHELLE ALFORD |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328197 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR 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 | 3 |
| Brand Name | PROSTHESIS - FLEX HA |
| Generic Name | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
| Product Code | ETA |
| Date Received | 2016-11-03 |
| Returned To Mfg | 2016-11-02 |
| Model Number | 0528 |
| Catalog Number | 0528 |
| Lot Number | 0210564932 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-03 |