MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-27 for REVITAN, RASP ADAPTER WITH LENGTH MARKINGS N/A 01.00409.501 manufactured by Zimmer Gmbh.
[107349484]
The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted photographs were received and will be reviewed as part of ongoing investigation. The device history records were reviewed and found to be conforming. An e-mail requesting the following additional information was sent on april 16, 2018 to the appropriate representatives. The availability of the affected product(s) (non-availability with a rationale), other reports (stickers), patient dob, weight, height, bmi and all relevant history. 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). Other case of the same surgery (jammed instrument) captured in (b)(4). The actual device reported in section d is not marketed in usa, but devices with similar characteristics (i. E adapter extractor) are marketed in usa, and therefore this report was filed.
Patient Sequence No: 1, Text Type: N, H10
[107349485]
It was reported that during impacting the distal revitan stem the revitan, rasp adapter with length markings got fractured. 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 | 0009613350-2018-00487 |
| MDR Report Key | 7467795 |
| Date Received | 2018-04-27 |
| Date of Report | 2018-08-03 |
| Date of Event | 2018-04-06 |
| Date Mfgr Received | 2018-07-12 |
| Device Manufacturer Date | 2010-05-28 |
| Date Added to Maude | 2018-04-27 |
| 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 | 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 | 2018-04-27 |
| Returned To Mfg | 2018-05-09 |
| Model Number | N/A |
| Catalog Number | 01.00409.501 |
| Lot Number | 10.543327 |
| 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. Other | 2018-04-27 |