MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-10-15 for BOXED CHISEL 72.13.02-10 manufactured by Zimmer Gmbh.
[22143432]
It was reported that a boxed chisel instrument was broken during surgery on (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
[22270604]
The manufacturer did not receive device and photos for review. Where lot number was received for the device, the device history records were reviewed and found to be conforming. 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. Zimmer's reference number of this file is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613350-2014-03992 |
| MDR Report Key | 4193963 |
| Report Source | 01,05 |
| Date Received | 2014-10-15 |
| Date of Report | 2014-09-17 |
| Date of Event | 2014-09-17 |
| Date Mfgr Received | 2014-09-17 |
| Device Manufacturer Date | 2014-02-01 |
| Date Added to Maude | 2014-10-27 |
| 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 | 574267613 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOXED CHISEL |
| Generic Name | BOXED CHISEL |
| Product Code | KDG |
| Date Received | 2014-10-15 |
| Returned To Mfg | 2014-09-30 |
| Catalog Number | 72.13.02-10 |
| Lot Number | 14.969832 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER GMBH |
| Manufacturer Address | SULZERALLEE 8 WINTERTHUR 8404 SZ 8404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-15 |