MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2013-12-02 for APPLIC-FORCEPS F/RAPIDSORB CRANIAL CLAMP 329.317 manufactured by Synthes Gmbh.
[4013172]
Device report from synthes (b)(4) reports an event in the (b)(6) as follows: facility reports that the cutting part of the instrument is not proven to be clean after ultrasonic washing. It is the opinion of the medical expert for sterility, this instrument cannot be cleaned according to regulations due to the construction of the device not being detachable. There was no patient involvement. This report is 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11258127]
Device is used for treatment, not diagnosis. Device is an instrument and is not implanted/explanted. Investigation is on-going. Subject device has been received and is currently in the evaluation process. No conclusion can be drawn. Review of manufacturing records has been requested. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[11610212]
Device was used for treatment, not diagnosis. Additional narrative: additional common device name hxz. The product development evaluation reported the customer states that the instrument will be treated as a single use instrument due to the lack of ability to clean. However, the clean instructions are shown by se_528721 and the state of the device is not consistent with a single use instrument. The returned device is well worn and shows obvious signs of wear and tear. The complained device is approved for cleaning and sterilization. The visual inspection performed as part of the additional evaluation indicated the device appears very worn and used, customer used marking tape on one handle. From a customer view this instrument is not easy to clean and check afterwards, because the cutting part is building a cave, which can? T be flushed easily. Nevertheless this has been regarded as a complex device (according to the design-features) and should show the recommended reduction of proteins? If our? Important information? Is followed exactly? Similar to our reference validations. The complaint was determined to be invalid. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[26395037]
A device history record review was conducted. The report indicates that the manufacturing documents were reviewed and no complaint related issues were found. Device was used for treatment, not diagnosis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-05347 |
| MDR Report Key | 3494700 |
| Report Source | 01,05,07 |
| Date Received | 2013-12-02 |
| Date of Report | 2013-11-04 |
| Date Mfgr Received | 2014-01-13 |
| Device Manufacturer Date | 2006-11-23 |
| Date Added to Maude | 2014-03-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JODI TEMPLE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES GMBH |
| Manufacturer Street | EIMATTSTRASSE 3 CH-4436 |
| Manufacturer City | OBERDORF |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APPLIC-FORCEPS F/RAPIDSORB CRANIAL CLAMP |
| Product Code | HXQ |
| Date Received | 2013-12-02 |
| Returned To Mfg | 2013-11-13 |
| Catalog Number | 329.317 |
| Lot Number | A7PA46 |
| 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 GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 CH-4436 OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-02 |