MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-11-12 for LEXER CHISEL 8.0/ 1.280 750892 manufactured by Zimmer Gmbh.
[4082828]
It has been reported that during the surgery the tip of the blade of the lexer chisel broke when it hit a screw that was stuck in cement.
Patient Sequence No: 1, Text Type: D, B5
[11256753]
An updated report will be submitted once the device is returned and investigated. At this time of the report no additional info has been received. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613350-2013-02030 |
| MDR Report Key | 3487511 |
| Report Source | 01,05 |
| Date Received | 2013-11-12 |
| Date of Report | 2013-10-16 |
| Date of Event | 2013-10-16 |
| Date Mfgr Received | 2013-10-16 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2013-12-27 |
| 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 | KEVIN ESCAPULE |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 5742676 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEXER CHISEL 8.0/ 1.280 |
| Generic Name | LEXER CHISEL |
| Product Code | KDG |
| Date Received | 2013-11-12 |
| Catalog Number | 750892 |
| Lot Number | 12794300 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2013-11-12 |