MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-14 for LONG SCALPEL HANDLE 03.010.491 manufactured by Synthes Monument.
[67657029]
Device is an instrument and is not implanted / explanted. Device history records review was completed for part#: 03. 010. 491, lot#: 7747165. Supplier: (b)(4), release to warehouse date: dec 16, 2014. No non conformance reports were generated during production. Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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
[67657030]
It was reported that the tip of the long scalpel handle broke off. The breakage occurred during sterilization. There was no procedure or patient involvement. There is an indentation on the shaft of the device that narrows down to a tip. The breakage occurred at the indentation and the tip of the device broke off. This report is for one (1) long scalpel handle. This is report 1 of 1 for com-(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[71128299]
Device was used for treatment, not diagnosis. A product development investigation was performed for the long scalpel handle (part number 03. 010. 491, lot number 7747165). The subject device was returned with the complaint condition stating the tip of the returned scalpel was confirmed to be broken off. The broken portion was not returned. The device has minor surface wear which does not impact functionality. The device is otherwise in good condition. A visual inspection, drawing review and dhr review were performed as part of this investigation. The complaint is confirmed. Replication of the complaint condition is not applicable as the device is already broken. No non-conformance records were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition. The design history was not found to impact the complaint condition. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. The returned parts were determined to be suitable for the intended use when employed. No definitive root cause was able to be determined. The broken tip was likely related to continued use and sterilization cycles over the life of the device. 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 | 1719045-2017-10106 |
| MDR Report Key | 6329960 |
| Date Received | 2017-02-14 |
| Date of Report | 2017-03-15 |
| Date Mfgr Received | 2017-03-15 |
| Device Manufacturer Date | 2014-12-16 |
| Date Added to Maude | 2017-02-14 |
| 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 | 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 MONUMENT |
| Manufacturer Street | 1051 SYNTHES AVE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LONG SCALPEL HANDLE |
| Generic Name | HANDLE, SCALPEL |
| Product Code | GDZ |
| Date Received | 2017-02-14 |
| Returned To Mfg | 2017-02-02 |
| Catalog Number | 03.010.491 |
| Lot Number | 7747165 |
| 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 MONUMENT |
| Manufacturer Address | 1051 SYNTHES AVE MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-14 |