MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-04-09 for PROBE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM 530.412 manufactured by Synthes Monument.
[3202144]
It is reported by synthes (b)(4) as follows: on (b)(6) 2012 the probe for compartmental pressure monitoring system did not function on the first use. The device was used for a second time and was noted that the cable connection on the end of the device was not sealed properly. This is 1 of 1 reported for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10656533]
Device was used for treatment, not diagnosis. Device is an instrument and is not implanted/explanted. The investigation could not be completed; no conclusion could be drawn, as no product was received. A review of device history records has been requested.
Patient Sequence No: 1, Text Type: N, H10
[10807935]
This device used for diagnosis and not treatment. A review of synthes device history records for lot us-27-1853 revealed the probe for compartmental pressure monitoring was manufactured by mipm (b)(4). Po (b)(4), dated (b)(4) 2012, for 1 part was inspected to the synthes incoming final inspection sheet. The product conformed to all requirements. The certificate of compliance was dated (b)(4) 2012. One part was released to the warehouse on (b)(4) 2012. No non conformances were generated during production. Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2013-00915 |
| MDR Report Key | 3042858 |
| Report Source | 01,07 |
| Date Received | 2013-04-09 |
| Date of Report | 2012-12-19 |
| Date of Event | 2012-12-12 |
| Date Mfgr Received | 2013-04-19 |
| Device Manufacturer Date | 2012-07-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHERRY LAING |
| 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 |
| Product Code | LXC |
| Date Received | 2013-04-09 |
| Catalog Number | 530.412 |
| Lot Number | US-27-1853 |
| 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 |