MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-08-20 for PROBE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM 530.412 manufactured by Synthes Usa.
[15783511]
It was reported on (b)(6) 2013, two compartmental pressure monitoring system probes failed during a demonstration test on a (b)(6) female at the office of a surgeon. The first probe recorded probe malfunction on the first attempt; the second attempt showed a 0. 0 reading. The probe functioned on the third attempt. The second probe did not produce any readings. Both probes were reported to be at approximately twenty of the twenty-five available readings. It was reported that the test result was negative with a reading of 14 to 15 mmhg and that there was no impact to the patient. This is report 2 of 2 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[15877725]
This device is used for diagnosis, not treatment. Device is an instrument and is not implanted/explanted. A review of synthes device history record for p/n 530. 412, revision? B? , lot # 6821766 (supplier lot # us-25-1591), revealed the probe for compartmental pressure monitoring system was manufactured by mipm (mammendorfer institut fur physik und medizin (b)(4)) and processed per specification requirements. The lot was inspected and accepted to the synthes inspection sheet # 503if412, revision? B?. There were no mrrs, ncrs, or complaint-related issues with this lot. The supplier? S certificate of compliance (c of c) is dated october 28, 2011. The lot was manufactured to the synthes source control drawing number 530. 412, revision? B? , released on april 15, 2004. 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
[26360989]
This device was used for diagnosis, not treatment. Subject device has been received and is currently in the evaluation process.
Patient Sequence No: 1, Text Type: N, H10
[28961186]
This device was used for diagnosis, not treatment. Additional narrative: manufacturing evaluation indicated mipm ((b)(4)) manufactured the probe for compartmental pressure monitoring system, p/n 530. 412, lot us-25-1591. The lot was processed per specification requirements, and previously 100 percent inspected and conformed to the synthes inspection sheet. The complaint issue was due to an unknown cause. The response of mipm dated september 13, 2013, stated the following: defect: soiled membrane of both probes. The membrane of both probes is soiled. Therefore, the offset is not stable and out of tolerance. The probes were not proper(ly) cleaned after usage.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-05161 |
| MDR Report Key | 3298902 |
| Report Source | 05,07 |
| Date Received | 2013-08-20 |
| Date of Report | 2013-07-25 |
| Date of Event | 2013-07-25 |
| Date Mfgr Received | 2013-10-03 |
| Device Manufacturer Date | 2011-11-16 |
| Date Added to Maude | 2013-11-18 |
| 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 | 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 | 2013-08-20 |
| Returned To Mfg | 2013-08-21 |
| Catalog Number | 530.412 |
| Lot Number | US-25-1591 |
| 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 USA |
| Manufacturer Address | WEST CHESTER PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-20 |