MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-08-06 for PROBE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM 530.412 manufactured by Synthes Usa.
[21460555]
It was reported that during a tibial fracture procedure two monitoring system probes failed. The probes were used for 3 readings, but when the fourth reading was attempted, it came back probe failure on the display. A second probe also failed, so a new probe cable was used and still did not work. Later a third probe was tested and worked with the new cable. This is report 3 of 3 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[21501143]
Device was used for diagnosis not treatment. Device is an instrument and is not implanted/explanted. A review of the device history records was performed and could not cross reference part number with synthes part number. Dhr could not be completed. Investigation could not be completed and no conclusion could be drawn as no device was returned. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-04679 |
| MDR Report Key | 3265660 |
| Report Source | 05,07 |
| Date Received | 2013-08-06 |
| Date of Report | 2013-07-09 |
| Date Mfgr Received | 2013-07-09 |
| Date Added to Maude | 2013-10-31 |
| 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 | W. LINDENMUTH |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROBE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM |
| Product Code | LXC |
| Date Received | 2013-08-06 |
| Catalog Number | 530.412 |
| Lot Number | UF161766 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | WEST CHESTER PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-06 |