MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-11-29 for REVITAN, RASP, DISTAL, CURVED, 16/140 N/A 01.00409.613 manufactured by Zimmer Gmbh.
[93256786]
X-rays and photographs were received and will be reviewed as part of ongoing investigation. The device was received, the investigation is pending. 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. Zimmer biomet? S reference number of this file is (b)(4). The actual device reported in section d is not marketed in usa, but devices with similar characteristics (i. E cls brevius kinectiv rasp sz8) are marketed in usa, and therefore this report was filed.
Patient Sequence No: 1, Text Type: N, H10
[93256787]
It was reported that during a surgery on (b)(4) 2017 the revitan, rasp, distal, curved, 16/140 could not be removed from the femur as expected. While removing the rasp it got broken. It was also reported that the surgery was delayed for 120 minutes. Notes: 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 | 0009613350-2017-01683 |
| MDR Report Key | 7068571 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-11-29 |
| Date of Report | 2018-04-09 |
| Date of Event | 2017-11-06 |
| Date Mfgr Received | 2018-04-05 |
| Device Manufacturer Date | 2014-12-24 |
| Date Added to Maude | 2017-11-29 |
| 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 | 3 |
| Brand Name | REVITAN, RASP, DISTAL, CURVED, 16/140 |
| Generic Name | N/A |
| Product Code | HTR |
| Date Received | 2017-11-29 |
| Returned To Mfg | 2017-11-22 |
| Model Number | N/A |
| Catalog Number | 01.00409.613 |
| Lot Number | 14.095943 |
| ID Number | UNKNOWN |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2017-11-29 |