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 2019-03-21 for CHISEL HANDLE 399.540 manufactured by Oberdorf Synthes Produktions Gmbh.
[139564087]
The device was received, and the product evaluation is in progress. No conclusion can be drawn. 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
[139564088]
Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2019, the hospital ordered a new chisel handle, but the bolt in it could not be moved. It was noticed right after the takeover before an unknown procedure, therefore this product could not be used during the surgery. There was no patient and procedure involvement when the allegation was reported. This report is for one (1) chisel-handle. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-62138 |
| MDR Report Key | 8440431 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-21 |
| Date of Report | 2019-02-25 |
| Date Mfgr Received | 2019-04-10 |
| Device Manufacturer Date | 2018-11-20 |
| Date Added to Maude | 2019-03-21 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | WERK BETTLACH (CH) |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH 2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHISEL HANDLE |
| Generic Name | CHISEL,BONE,SURGICAL |
| Product Code | EML |
| Date Received | 2019-03-21 |
| Returned To Mfg | 2019-03-11 |
| Catalog Number | 399.540 |
| Lot Number | 2L22897 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-21 |