MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-07-14 for PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE 399.360 manufactured by Synthes Bettlach.
[12182526]
Additional narrative: a manufacturing evaluation was completed: the investigation has shown that the front part of the instrument is indeed broken / snapped off. The review of the production history revealed that this article was manufactured according to the specifications (manufactured in march 2004). No manufacturing related issues that would have contributed to this complaint were found. The fracture surface is homogenous, which indicates material conformity as well. Based on these findings we conclude that the cause of failure is related to a mechanical overloading during use over the years. No product fault could be detected. 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
[19922262]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the periosteal elevator snapped with very little pressure exerted. Device snapped into two pieces and nothing was left in patient. Alternate device was used to complete the case. There was no delay to procedure and harm to the patient. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[20263086]
Device is an instrument and is not implanted/explanted. A review of the device history records was requested, but device history records were not available as device is older than ten years. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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 | 9612488-2014-10279 |
| MDR Report Key | 3932979 |
| Report Source | 01,05,07 |
| Date Received | 2014-07-14 |
| Date of Report | 2014-06-16 |
| Date of Event | 2014-06-16 |
| Date Mfgr Received | 2014-07-31 |
| Device Manufacturer Date | 2004-03-23 |
| Date Added to Maude | 2014-07-25 |
| 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 | 0 |
| Event Location | 0 |
| 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 |
| Manufacturer G1 | SYNTHES BETTLACH |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH CH2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE |
| Generic Name | ELEVATOR |
| Product Code | HTE |
| Date Received | 2014-07-14 |
| Returned To Mfg | 2014-06-30 |
| Catalog Number | 399.360 |
| Lot Number | 5003495 |
| 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 BETTLACH |
| Manufacturer Address | MURACHERSTRASSE 3 BETTLACH CH2544 SZ CH2544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-14 |