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 2016-02-01 for CHISEL HANDLE 399.540 manufactured by Synthes Bettlach.
[37238094]
It is unknown if there was any patient involvement. 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). Manufacturing location: (b)(4). Manufacturing date: november 12, 2013. No non-conformance reports were generated during production that would contribute to the complaint condition. The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition. 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
[37238095]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the blade of the instrument retaining the screw has broken. It is not known when this happened. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612488-2016-10070 |
| MDR Report Key | 5401836 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-02-01 |
| Date of Report | 2016-01-18 |
| Date Mfgr Received | 2016-01-18 |
| Device Manufacturer Date | 2013-11-12 |
| Date Added to Maude | 2016-02-01 |
| 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 | 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 | CHISEL HANDLE |
| Generic Name | CHISEL, BONE, SURGICAL |
| Product Code | EML |
| Date Received | 2016-02-01 |
| Catalog Number | 399.540 |
| Lot Number | 8682977 |
| ID Number | (01)07611819027909(10)8682977 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-02-01 |