MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-05-14 for RONGEUR PITUITARY CER BLACK SERRATED 3MM 8733-7183 manufactured by Zimmer Biomet Spine Inc..
[145091747]
Udi number: ni. Without a product return, no product evaluation is able to be conducted. The lot number is unknown; therefore the device history records are unable to be reviewed. 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
[145091748]
It was reported that the tip of a rongeur broke during surgery. The fractured piece was retrieved and an alternative device was not needed to complete the procedure. There were no reported patient impacts.
Patient Sequence No: 1, Text Type: D, B5
[168470748]
It was reported that the tip of a rongeur broke during surgery. The fractured piece was retrieved and an alternative device was not needed to complete the procedure. There were no reported patient impacts.
Patient Sequence No: 1, Text Type: D, B5
[169085263]
Current information is insufficient to permit a valid conclusion about the cause of this event. A follow up report will be sent upon completion of the device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[169085264]
It was reported that the tip of a rongeur broke during surgery. The fractured piece was retrieved and an alternative device was not needed to complete the procedure. There were no reported patient impacts.
Patient Sequence No: 1, Text Type: D, B5
[169247275]
Additional information: udi number, method, results, and conclusions - the returned rongeur was examined. The jaw of the device had disassembled due to the fracture of the associated pivot pin. It is possible that the pivot pin had weakened from use/handling/cleaning/sterilization over time or from applying an extreme force to the handle that overcame the mechanical capabilities of the pin leading to the fracture seen. A review of the dhr did not find any issues which would have contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
[169247276]
It was reported that the tip of a rongeur broke during surgery. The fractured piece was retrieved and an alternative device was not needed to complete the procedure. There were no reported patient impacts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012447612-2019-00227 |
| MDR Report Key | 8610085 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-05-14 |
| Date of Report | 2019-11-26 |
| Date of Event | 2019-03-12 |
| Date Mfgr Received | 2019-10-31 |
| Device Manufacturer Date | 2017-07-18 |
| Date Added to Maude | 2019-05-14 |
| 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. ASHLEY MCPHERSON |
| 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 | RONGEUR PITUITARY CER BLACK SERRATED 3MM |
| Generic Name | RONGEUR |
| Product Code | HTX |
| Date Received | 2019-05-14 |
| Returned To Mfg | 2019-06-04 |
| Model Number | NA |
| Catalog Number | 8733-7183 |
| Lot Number | IM00292 |
| 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 BIOMET SPINE INC. |
| Manufacturer Address | 10225 WESTMOOR DR. NA WESTMINSTER CO 80021 US 80021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-14 |