MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-01 for IMPACTOR, 32 N/A 840.6024 manufactured by Zimmer Gmbh.
[76526935]
The product was received for investigation and the investigation has been initiated. Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming. A cause for this specific event cannot be ascertained from the information provided. Additional information was requested to the appropriate representatives. 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 cmp-(b)(4). Investigation initiated.
Patient Sequence No: 1, Text Type: N, H10
[76526936]
During the surgery on (b)(6) 2017, the impactor got broken. Surgery was completed with another device. Note: the implantation and explantation dates are left empty as the device involved in this complaint is an instrument. Hence, no expiration date is captured, for the same reason.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009613350-2017-00759 |
| MDR Report Key | 6604129 |
| Date Received | 2017-06-01 |
| Date of Report | 2017-06-01 |
| Date of Event | 2017-05-08 |
| Date Mfgr Received | 2017-08-31 |
| Device Manufacturer Date | 2016-07-12 |
| Date Added to Maude | 2017-06-01 |
| 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 | MR. KEVIN ESCAPULE |
| Manufacturer Street | 1800 WEST CENTER STREET |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal | 46580 |
| Manufacturer Phone | 8006136131 |
| Manufacturer G1 | ZIMMER GMBH |
| Manufacturer Street | SULZER ALLEE 8 SULZER INDUSTRIE PARK |
| Manufacturer City | WINTERTHUR 8404 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IMPACTOR, 32 |
| Generic Name | IMPACTOR, 32 |
| Product Code | HSZ |
| Date Received | 2017-06-01 |
| Returned To Mfg | 2017-05-17 |
| Model Number | N/A |
| Catalog Number | 840.6024 |
| Lot Number | 16.302433 |
| ID Number | 00889024383289 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER GMBH |
| Manufacturer Address | SULZER ALLEE 8 SULZER INDUSTRIE PARK WINTERTHUR 8404 SZ 8404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-01 |