MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-08-14 for CHISEL HANDLE 399.54 manufactured by Synthes Bettlach.
[23124191]
Device used for treatment, not diagnosis. Subject device has been received; no conclusions could be drawn as the device is entering the complaint system. A review of the service history records has been requested and is pending completion. Device 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
[23124192]
It was reported that the screw that holds the chisel onto the handle broke during a surgical procedure. Another instrument was immediately available. It is unknown if there was a surgical delay. No further information is available. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[25396911]
Additional narrative: service history review: no service history review can be performed as this is a lot controlled item. The manufacture date of this item is 18 september 2014. The source of the manufacture date is the release to warehouse date. The service history evaluation is unconfirmed. Device is an instrument and is not implanted/explanted. 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
[30275035]
Additional narrative: subject device has been received and a service and repair evaluation was performed: the customer reported the screw that held the chisel on the handle broke. The repair technician reported the hex screw was missing. Missing parts is the reason for repair. The cause of the issue is unknown. The following parts were replaced: hex screw i. This item was repaired, passed synthes final inspection and returned to the customer on 27-aug-2015. The evaluation was confirmed. 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
[31208948]
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
| Report Number | 9612488-2015-10412 |
| MDR Report Key | 5005430 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-08-14 |
| Date of Report | 2015-07-28 |
| Date Mfgr Received | 2015-09-22 |
| Device Manufacturer Date | 2014-09-18 |
| Date Added to Maude | 2015-08-14 |
| 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 CO 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 | 2015-08-14 |
| Returned To Mfg | 2015-08-21 |
| Catalog Number | 399.54 |
| Lot Number | 9132175 |
| 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 CO CH2544 SZ CH2544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-14 |