MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-30 for PERIOSTEAL ELEVATOR 3MM CURVED BLADE - STRAIGHT EDGE 399.48.96 manufactured by Synthes Tuttlingen.
[84955564]
There was no known reported patient involvement associated with the complained event. Date of event is unknown. Device is an instrument and is not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. (b)(6). A device history record (dhr) review was requester for part # 399. 48. 96 / lot # a7ia49: a device history record review could not be performed as part number and lot number unknown at synthes (b)(4). The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[84955565]
It was reported that screw driver wooden handles from a modular hand system are bleeding and leaving stains on the lids and causing a concern. There is no patient involved as this is happening in sterile processing department. This report is for one (1) periosteal elevator 3mm curved blade-straight edge. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1719045-2017-10859 |
| MDR Report Key | 6832117 |
| Date Received | 2017-08-30 |
| Date of Report | 2017-08-09 |
| Date Mfgr Received | 2017-10-05 |
| Date Added to Maude | 2017-08-30 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN CO 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PERIOSTEAL ELEVATOR 3MM CURVED BLADE - STRAIGHT EDGE |
| Generic Name | ELEVATOR |
| Product Code | HTE |
| Date Received | 2017-08-30 |
| Returned To Mfg | 2017-08-30 |
| Catalog Number | 399.48.96 |
| Lot Number | A7MA06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES TUTTLINGEN |
| Manufacturer Address | UNTER HASSLEN 5 TUTTLINGEN CO 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-30 |