MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-04-09 for CALIPER 03.501.065 manufactured by Synthes Monument.
[3392488]
The caliper (03. 501. 065) has rust along the tightening screw and caliper edges. This was noticed during a procedure, and the surgeon completed the procedure with no harm to patient. The surgeon wants instrument removed from the matrix rib set. Calipers will not be returned.
Patient Sequence No: 1, Text Type: D, B5
[10612751]
Additional narrative: synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012. Device(s) listed in this report is (are) used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. A review of the device history records was performed and no complaint related issues were found. Investigation could not be completed and no conclusion could be drawn as no device was returned.
Patient Sequence No: 1, Text Type: N, H10
[28586974]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012. Blank fields on this form indicate the information is unknown, unavailable or unchanged. Device(s) listed in this report is (are) used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[28586975]
This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1719045-2013-10602 |
| MDR Report Key | 3044641 |
| Report Source | 05,07 |
| Date Received | 2013-04-09 |
| Date of Report | 2011-09-28 |
| Date Mfgr Received | 2011-09-28 |
| Device Manufacturer Date | 2009-08-28 |
| Date Added to Maude | 2013-06-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | T. MCCARRON |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES MONUMENT |
| Manufacturer Street | 1101 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 | CALIPER |
| Product Code | FTY |
| Date Received | 2013-04-09 |
| Catalog Number | 03.501.065 |
| Lot Number | 4815704 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES MONUMENT |
| Manufacturer Address | 1101 SYNTHES AVE MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-09 |