MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-09 for MIS, RASP HANDLE, DOUBLE OFFSET, LEFT N/A 01.00001.003 manufactured by Zimmer Gmbh.
[116874656]
(b)(4). The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device for investigation. The device history records were reviewed and found to be conforming. Additional information has been requested and is currently not available. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available, an updated report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[116874657]
It was reported that the rasp handle was stuck in the lock position. The surgeon had to use another device to complete the surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009613350-2018-00786 |
| MDR Report Key | 7766599 |
| Date Received | 2018-08-09 |
| Date of Report | 2018-12-07 |
| Date of Event | 2018-07-23 |
| Date Mfgr Received | 2018-11-27 |
| Device Manufacturer Date | 2017-09-28 |
| Date Added to Maude | 2018-08-09 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| 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 | MIS, RASP HANDLE, DOUBLE OFFSET, LEFT |
| Generic Name | N/A |
| Product Code | HTR |
| Date Received | 2018-08-09 |
| Returned To Mfg | 2018-09-27 |
| Model Number | N/A |
| Catalog Number | 01.00001.003 |
| Lot Number | 4501770665 |
| 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 | 2018-08-09 |