MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-07 for REVITAN, RASP ADAPTER WITH LENGTH MARKINGS N/A 01.00409.501 manufactured by Zimmer Gmbh.
[116706562]
This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states (b)(4). The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation. As no lot number was provided, the device history records could not be reviewed. An e-mail requesting the following additional information was sent on (b)(6) 2018 to the appropriate representatives. 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).
Patient Sequence No: 1, Text Type: N, H10
[116706563]
It was reported that during the surgery, the rear portion of the handle of the revitan, rasp adapter with length markings has broken off and the surgery was completed with the defective instrument. No surgery delay has been reported. 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 | 0009613350-2018-00688 |
| MDR Report Key | 7755620 |
| Date Received | 2018-08-07 |
| Date of Report | 2018-10-11 |
| Date of Event | 2018-06-14 |
| Date Mfgr Received | 2018-10-03 |
| Device Manufacturer Date | 2012-09-17 |
| Date Added to Maude | 2018-08-07 |
| 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 | REVITAN, RASP ADAPTER WITH LENGTH MARKINGS |
| Generic Name | N/A |
| Product Code | HTR |
| Date Received | 2018-08-07 |
| Returned To Mfg | 2018-07-25 |
| Model Number | N/A |
| Catalog Number | 01.00409.501 |
| Lot Number | 12.783902 |
| 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 | 2018-08-07 |