MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-08-26 for PROBE FOR CPMS 530.412 manufactured by Depuy Synthes Power Tools.
[4903170]
It was reported that during engineering evaluation, it was observed that the probe device had temperature above specification. The event was not related to surgery. There was no patient involvement. There were no injuries or medical intervention associated with this event. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
[12185666]
The manufacturing location was unknown. The device manufacture date is unknown. The actual device was returned for evaluation. Reliability engineering evaluated the device and observed that the temperature was above specification. The reported condition was confirmed. The assignable root cause was determined to be due to normal wear and servicing over time. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
[26884046]
Correction: upon further investigation, it was determined that mfr# 2520274-2014-13088 is a duplicate of mfr# 2520274-2014-10911. Reference 2520274-2014-10911 for all further reporting regarding this event. If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2014-13088 |
| MDR Report Key | 4039082 |
| Report Source | 05,07 |
| Date Received | 2014-08-26 |
| Date of Report | 2014-08-06 |
| Date of Event | 2014-08-06 |
| Date Mfgr Received | 2015-02-24 |
| Date Added to Maude | 2014-09-09 |
| 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 | SERVICE AND TESTING PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Street | NI NI |
| Manufacturer City | NI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROBE FOR CPMS |
| Generic Name | MONITOR, PRESSURE, INTRACOMPARTMENT |
| Product Code | LXC |
| Date Received | 2014-08-26 |
| Returned To Mfg | 2014-04-11 |
| Catalog Number | 530.412 |
| Lot Number | 25-1585 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Address | N/I N/I US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-26 |