MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-12 for PROBE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM 530.412 manufactured by Synthes Monument.
[38751129]
Additional patient information: patient height reported as (b)(6). Patient initials are (b)(6). (b)(4). Device is an instrument and is not implanted or explanted. Subject device has been received; no conclusions could be drawn as the device is entering the complaint system. Device history record review: manufacturing date: july 8, 2014 - manufacturing site: (b)(4). No non-conformance reports were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition. Device used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[38751130]
It was reported that a compartment pressure monitoring probe failed to read during an external fixation procedure of a bilateral tibia on (b)(6) 2016. The device was slid into the intravenous catheter and then pulled back to expose the probe, but not reading was registered. After about thirty (30) seconds, the device read? Probe malfunction.? The device was then retrieved and an arterial line used to pass through in order to obtain the reading. As a result, there was a five (5) to eight (8) minute delay. At the time of the report, the procedure was still in process, but said to be successful. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[38824553]
The awareness date on the initial medwatch was entered as june 20, 2016 in error. The correct date of awareness was january 20, 2016. Device used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[40032417]
Manufacturing investigation evaluation: the reported chip was not cleaned after use. The customer report that the cpms probe ((b)(4)) had no reading at all. The monitoring unit said probe malfunction after thirty (30) seconds. As soon as the device malfunction was realized, the surgeon retrieved an arterial line and passed the line through to get a reading instead. The issue was confirmed. The probes were sent to mipm mammendorfer institute for evaluation and found to display an error, which was due to the chip not being properly cleaned after use. Since the device failure was caused by user misuse/abuse and is not related to any device nonconformity or manufacturing process failure, no further investigation is required at this time. Device used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2016-10128 |
| MDR Report Key | 5434169 |
| Date Received | 2016-02-12 |
| Date of Report | 2016-01-20 |
| Date of Event | 2016-01-20 |
| Date Mfgr Received | 2016-02-26 |
| Device Manufacturer Date | 2014-07-08 |
| Date Added to Maude | 2016-02-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES MONUMENT |
| Manufacturer Street | 1051 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 | MONITOR, PRESSURE, INTRACOMPARTMENT |
| Product Code | LXC |
| Date Received | 2016-02-12 |
| Returned To Mfg | 2016-02-03 |
| Catalog Number | 530.412 |
| Lot Number | US-29-2131 |
| 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 | 1051 SYNTHES AVE MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-12 |