MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-02-20 for CALIPER 03.501.065 manufactured by Synthes Monument.
[18309702]
It was reported that during a procedure the caliper was found rusted at the numbers. Consultant checked the set and another caliper was found rusted. This is report 1 of 2 for the same event.
Patient Sequence No: 1, Text Type: D, B5
[18324367]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated (b)(4) 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. Device history record review revealed no issues that would contribute to the reported issue. The suppliers certification indicate the correct material and hardness values were obtained. Visual inspection of the caliper revealed the graduation marks on the slider, the ce mark on the body and the head of the screw are rusted. The etched logo, part number and lot number on the body are not rusting. The components in question are passivated, the supplier records indicate these processes were performed per the synthes procedure. Conclusion: the complaint is indeterminate from a manufacturing standpoint because passivation is defined as a special process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2013-10117 |
| MDR Report Key | 3035877 |
| Report Source | 05,07 |
| Date Received | 2013-02-20 |
| Date of Report | 2011-02-11 |
| Date of Event | 2011-02-11 |
| Date Mfgr Received | 2013-01-22 |
| Device Manufacturer Date | 2010-04-01 |
| Date Added to Maude | 2013-05-01 |
| 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 19880 |
| Manufacturer Country | US |
| Manufacturer Postal | 19880 |
| 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 | KTZ |
| Date Received | 2013-02-20 |
| Returned To Mfg | 2011-02-28 |
| Catalog Number | 03.501.065 |
| Lot Number | 6280683 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES MONUMENT |
| Manufacturer Address | MONUMENT CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-20 |