MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-09-17 for OSCILL-SAW 518.010 manufactured by Synthes Gmbh.
[16173003]
The customer reported that the saw often sticks during the femoral head surgery. The saw performance was weaker compared to a second identical saw. This is report 1 of 1 for event # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[16386101]
Additional narrative: synthes is submitting this report as a result of remediation activities related to synthes service and repair files legacy review/remediation protocol-complaint handling and mdr reporting. Device listed in this report is used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. Device is not distributed in the united states, but is similar to device marketed in the usa. During pre-repair assessment performed by technician, found that the device has not been properly maintenance or serviced and the poor performance was due to normal wear. The device was serviced and returned to the customer on (b)(4) 2012. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2014-01319 |
| MDR Report Key | 4097170 |
| Report Source | 01,05 |
| Date Received | 2014-09-17 |
| Date of Report | 2012-10-18 |
| Date Mfgr Received | 2012-10-18 |
| Device Manufacturer Date | 1999-09-28 |
| Date Added to Maude | 2014-09-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES GMBH |
| Manufacturer Street | EIMATTSTRASSE 3 CH-4436 |
| Manufacturer City | OBERDORF |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSCILL-SAW |
| Product Code | EWQ |
| Date Received | 2014-09-17 |
| Returned To Mfg | 2012-10-18 |
| Catalog Number | 518.010 |
| Lot Number | 6406 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 CH-4436 OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-17 |