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 2017-03-21 for WERBER COUNTERSINK CANNF.MIRCOCBSSCRS AO N/A 503004541 manufactured by Zimmer Gmbh.
[70422532]
The manufacturer received the device for investigation. The investigation is pending. Additional information has been requested and is currently not available. A cause for this specific event cannot be ascertained from the information provided. Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[70422533]
It was reported that a werber countersink cannf. Mircocbsscrs ao was used in a surgery on (b)(6) 2016. This product broke during surgery and a piece remained in patient's body. There is no medical intervention. No contributing conditions related to the event. The surgery was completed with another device. Additional information has been requested and is currently not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009613350-2017-00418 |
| MDR Report Key | 6420254 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-03-21 |
| Date of Report | 2017-03-20 |
| Date of Event | 2016-08-25 |
| Date Mfgr Received | 2017-06-22 |
| Device Manufacturer Date | 2014-06-24 |
| Date Added to Maude | 2017-03-21 |
| 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 | 3 |
| Brand Name | WERBER COUNTERSINK CANNF.MIRCOCBSSCRS AO |
| Generic Name | UNKNOWN |
| Product Code | HWW |
| Date Received | 2017-03-21 |
| Returned To Mfg | 2016-10-26 |
| Model Number | N/A |
| Catalog Number | 503004541 |
| Lot Number | 15350 |
| ID Number | 00889024111967 |
| Operator | LAY USER/PATIENT |
| 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 | 2017-03-21 |