MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-11-30 for PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE 399.48 manufactured by Synthes Usa.
[32291029]
(b)(4). Device is an instrument and is not implanted/explanted. Without a lot number the device history records review could not be completed. Subject device has been received and is currently in the evaluation process. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[32291030]
It was reported a piece of a handle broke off a periosteal elevator during decontamination and washing of the device. The device is available for return but, the broken piece was discarded and not available for return. This event did not occur during surgery. There was no surgical delay. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[33906586]
Subject device has been received and an investigation summary was performed. The investigation of the complaint articles has shown that: during sterile processing a periosteal elevator handle broke; there was no surgical or patient involvement. The returned instrument (399. 48 lot unknown) was examined and the complaint condition was able to be confirmed as the device handle was broken and a distal portion was found to be missing and not returned. No definitive root cause was able to be determined however the failure mode is consistent with wear/tear of the instrument? S phenolic handle which is susceptible to becoming brittle after being subjected to years of thermal cycling which routinely occurs during sterilization. This investigation summary is approved. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[33949579]
Date on follow-up was reported as oct. 1, 2015, but suppose to be dec 1, 2015. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2015-17515 |
| MDR Report Key | 5254240 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-11-30 |
| Date of Report | 2015-11-10 |
| Date Mfgr Received | 2015-12-21 |
| Date Added to Maude | 2015-11-30 |
| 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 | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE |
| Generic Name | ELEVATOR |
| Product Code | HTE |
| Date Received | 2015-11-30 |
| Returned To Mfg | 2015-11-19 |
| Catalog Number | 399.48 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-30 |