MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-04-27 for ZIMMER JOINT CAPSULE SCISSORS N/A 75.00.42 manufactured by Zimmer Gmbh.
[73788440]
The manufacturer receive the devices and the investigation is ongoing. A picture was received where lot numbers were received for the devices, the device history records were reviewed and found to be conforming. A cause for this specific event cannot be ascertained from the information provided. Additional information was requested and received on april 12, 2017. Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted. Zimmer? S reference number of this file is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[73788441]
It was reported that the surgeon used the zimmer joint capsule scissors and during the surgery the tip of one side of the scissors broke. No pieces were left in the patient. Note: 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 | 0009613350-2017-00550 |
| MDR Report Key | 6525278 |
| Report Source | FOREIGN |
| Date Received | 2017-04-27 |
| Date of Report | 2017-04-26 |
| Date of Event | 2017-03-30 |
| Date Mfgr Received | 2017-08-14 |
| Device Manufacturer Date | 2009-07-31 |
| Date Added to Maude | 2017-04-27 |
| 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 | 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 | ZIMMER JOINT CAPSULE SCISSORS |
| Generic Name | ZIMMER JOINT CAPSULE SCISSORS |
| Product Code | HRR |
| Date Received | 2017-04-27 |
| Returned To Mfg | 2017-04-25 |
| Model Number | N/A |
| Catalog Number | 75.00.42 |
| Lot Number | 09.464738 |
| ID Number | 00889024302389 |
| Operator | PHYSICIAN |
| 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 | 2017-04-27 |