MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-12-14 for PROBE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM 530.412 manufactured by Synthes Monument.
[3246662]
The probe for compartmental pressure monitoring system stopped functioning while in use. The physician moved the tip around and was able to get a reading when the device stopped functioning again. The test was cancelled when the physician could not achieve accurate readings from the device. The patient was transferred to orthopedics. The physician was aware that the patient's pressure was elevated prior to testing.
Patient Sequence No: 1, Text Type: D, B5
[10289078]
This device is used for diagnosis not treatment. Subject device has been received and is currently in the evaluation process. Investigation is on going; no conclusion could be drawn. A review of the device history records showed that the probe for compartmental pressure monitoring system was processed per specification requirements. The lot was inspected and accepted per specification. They were no complaint related issues with this lot.
Patient Sequence No: 1, Text Type: N, H10
[10515269]
Manufacturing engineer evaluated the device and indicated that ((b)(4)) manufactured the probe for compartmental pressure monitoring system. The lot was processed per specification requirements, and previously inspected / conformed to the synthes inspection sheet. The complaint issue was due to an unknown cause. A response from (b)(4) dated (b)(4) 2013 and further communication, revealed no failure was found during the evaluation, and (b)(4) was unable to find any fault with the probe.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2012-01365 |
| MDR Report Key | 2874021 |
| Report Source | 05,07 |
| Date Received | 2012-12-14 |
| Date of Report | 2012-11-15 |
| Date of Event | 2012-11-14 |
| Date Mfgr Received | 2013-01-15 |
| Device Manufacturer Date | 2012-05-04 |
| Date Added to Maude | 2013-03-19 |
| 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 | C BALL |
| 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 | PROBE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM |
| Generic Name | PROBE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM |
| Product Code | LXC |
| Date Received | 2012-12-14 |
| Returned To Mfg | 2012-12-10 |
| Catalog Number | 530.412 |
| Lot Number | US-16-1782 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2012-12-14 |