MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-03-06 for PITUITARY RONGEUR BLACK 3MM LATERAL 8733-7153 manufactured by Zimmer Biomet Spine Inc..
[101724683]
Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
[101724684]
It was reported that a rongeur was found broken in the bottom of the wash after cleaning. There was no surgery or patient associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[122216874]
The returned rongeur was examined. The jaw was found to have fracture near the pivot joint. The cause cannot be determined since it is unknown how the device was being used or handled at the time of the breakage. A review of the dhr did not identify any manufacturing related issues which would have contributed to this event. The labeling was reviewed and found to contain instructions regarding proper device usage.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012447612-2018-00240 |
| MDR Report Key | 7319231 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-03-06 |
| Date of Report | 2018-09-28 |
| Date Mfgr Received | 2018-09-04 |
| Device Manufacturer Date | 2014-11-03 |
| Date Added to Maude | 2018-03-06 |
| 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. GEOFFREY GANNON |
| Manufacturer Street | 10225 WESTMOOR DR. NA |
| Manufacturer City | WESTMINSTER CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal | 80021 |
| Manufacturer Phone | 3034437500 |
| Manufacturer G1 | ZIMMER BIOMET SPINE INC. |
| Manufacturer Street | 10225 WESTMOOR DR. NA |
| Manufacturer City | WESTMINSTER CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PITUITARY RONGEUR BLACK 3MM LATERAL |
| Generic Name | RONGEUR |
| Product Code | HTX |
| Date Received | 2018-03-06 |
| Returned To Mfg | 2018-02-07 |
| Model Number | NA |
| Catalog Number | 8733-7153 |
| Lot Number | IM00154 |
| ID Number | NA |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET SPINE INC. |
| Manufacturer Address | 10225 WESTMOOR DR. NA WESTMINSTER CO 80021 US 80021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-06 |