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 2019-01-14 for LONG SCALPEL HANDLE 03.010.491 manufactured by Oberdorf Synthes Produktions Gmbh.
[133211350]
Complainant part is not expected to be returned for manufacturer review/investigation. Occupation: initial reporter is a synthes employee. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. A review of the device history records has been requested. 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
[133211351]
Device report from synthes (b)(4) reports an event as follows: it was reported on (b)(6) 2018, before an unknown surgery, the hospital found that the tip of the scalpel handle was broken. The handle was not used in the surgery. It is unknown how the issue was discovered. There was no adverse consequence to the patient. This report is for a scalpel handle. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-59858 |
| MDR Report Key | 8245447 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-14 |
| Date of Report | 2018-12-19 |
| Date Mfgr Received | 2019-03-13 |
| Device Manufacturer Date | 2015-11-20 |
| Date Added to Maude | 2019-01-14 |
| 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 |
| 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 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| 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 | 2019-01-14 |
| Returned To Mfg | 2019-01-14 |
| Catalog Number | 03.010.491 |
| Lot Number | 9854588 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-01-14 |