MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-09 for PERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGE 399.400 manufactured by Synthes Salzburg.
[89148206]
Patient identifier and weight not available for reporting. 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). The investigation could not be completed; no conclusion could be drawn, as no product was received. Dhr review was completed. Manufacturing location: (b)(4). Manufacturing date: 03. Sep. 2008 no ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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
[89148207]
It was reported that during an unknown procedure on (b)(6) 2017 the periosteal elevator broke. The broken off fragment remained in the joint and was difficult to extract. Risk of vascular-nervous lesions due to the difficulty of extraction and infectious risk due to the foreign body in intra-articular. The fragment was removed. The surgery was prolonged about 45 minutes. Patient condition reported as fine. This report is for one (1) periosteal elevator 6mm curved blade-straight edge. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009417901-2017-10021 |
| MDR Report Key | 6931400 |
| Date Received | 2017-10-09 |
| Date of Report | 2017-09-22 |
| Date of Event | 2017-08-22 |
| Date Mfgr Received | 2017-11-24 |
| Device Manufacturer Date | 2008-09-03 |
| Date Added to Maude | 2017-10-09 |
| 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 | PHARMACIST |
| 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 SALZBURG |
| Manufacturer Street | KAROLINGERSTRASSE |
| Manufacturer City | SALZBURG 5020 |
| Manufacturer Country | AU |
| Manufacturer Postal Code | 5020 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGE |
| Generic Name | ELEVATOR |
| Product Code | HTE |
| Date Received | 2017-10-09 |
| Returned To Mfg | 2017-10-26 |
| Catalog Number | 399.400 |
| Lot Number | 5801591 |
| 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 SALZBURG |
| Manufacturer Address | KAROLINGERSTRASSE SALZBURG 5020 AU 5020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-10-09 |