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 2015-09-17 for CHISEL HANDLE 399.540 manufactured by Synthes Bettlach.
[26015567]
Additional narrative: device is an instrument and is not implanted/explanted. (b)(6). The investigation could not be completed; no conclusion could be drawn, as no product was received. Manufacturing location: (b)(4). Manufacturing date: 25july2014. No non-conformance reports 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
[26015608]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: the screw head broke while using the screwdriver to turn it to lock the chisel blades. There was a surgery prolongation of twenty (20) minutes. This report is for an unknown screw. This is report 2 of 4 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[27370732]
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
[27370733]
Patient condition reported as fine. This is report 1 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[28633912]
Additional narrative: a manufacturing investigation action was conducted/performed. The report indicates that: a dhr review was performed for the affected lot, no abnormalities or deviations were detected, which could lead to the complaint failure. All dimensions and parameters which could lead to the complaint were measured, and fulfill the specifications. Also the hardness of the screw was measured with the result, that it meets the specifications. Based on this the complaint is rated as confirmed but not as valid from the point of view of the manufacturing site. As the part was manufactured according to the specification, mechanical overloading would be most probably root cause for the breakage of the screw. No manufacturing related issue was identified and confirmed, therefore review to the specific prm and prm line is not applicable. 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
[30275037]
Additional narrative: 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
[30275038]
This report is for a chisel handle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612488-2015-10476 |
| MDR Report Key | 5083754 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-09-17 |
| Date of Report | 2015-09-01 |
| Date of Event | 2015-09-01 |
| Date Mfgr Received | 2015-10-05 |
| Device Manufacturer Date | 2014-07-25 |
| Date Added to Maude | 2015-09-17 |
| 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 | 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 | 2015-09-17 |
| Returned To Mfg | 2015-09-21 |
| Catalog Number | 399.540 |
| Lot Number | 9062800 |
| 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 | 2015-09-17 |