MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,foreign,other report with the FDA on 2015-05-01 for FLAT CURVED CHISEL, 16MM 75.16.12 manufactured by Zimmer Gmbh.
[5774897]
It was reported that "the medical devices with handles made of ferrozell material lead to discoloration/residues in the container after the sterilization and instruments that can be hygienically questionable, or at least making the user and (b)(6) staff uncomfortable. "
Patient Sequence No: 1, Text Type: D, B5
[13430756]
The manufacturer did not receive devices, x-rays, or other source documents for review. As no lot numbers were provided for the devices, the device history records could not be reviewed. A cause for this specific event cannot be ascertained from the information provided. Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[64285316]
The device was not returned for investigation. The dhr check could not be performed as the lot number was not available. Handles made out of canevasit leads to discoloration/residues. As investigating to the case at hand, zimmer (b)(4) found parallels between this experience and that of other users of canevasit handles. As a reaction to those earlier reports zimmer (b)(4) already performed a concise analysis and have been able to identify the root cause that also explains the event of that experience. The root cause is inappropriate product specifications. Appropriate corrective and preventive actions were already implemented. The handle material of identified instruments was changed from canevasit to ppsu or metal. As error pattern and root cause are already known and appropriate measures were taken, zimmer (b)(4) considers this case as closed. Zimmer's reference number of this file is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613350-2015-00502 |
| MDR Report Key | 4751509 |
| Report Source | 00,01,FOREIGN,OTHER |
| Date Received | 2015-05-01 |
| Date of Report | 2015-04-20 |
| Date of Event | 2015-01-27 |
| Date Mfgr Received | 2015-07-03 |
| Date Added to Maude | 2015-06-11 |
| 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 | KEVIN ESCAPULE |
| Manufacturer Street | PO BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 5712676 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLAT CURVED CHISEL, 16MM |
| Generic Name | FLAT, CURVED CHISEL, 16MM |
| Product Code | EML |
| Date Received | 2015-05-01 |
| Catalog Number | 75.16.12 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER GMBH |
| Manufacturer Address | SULZER ALLEE 8 WINTERTHUR 8404 SZ 8404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-01 |