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 2019-06-24 for ROD BENDER 2000-9044 manufactured by Zimmer Biomet Spine Inc..
[148996670]
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
[148996671]
It was reported that when a tray was opened during surgery, the french rod bender was found to be disassembled. It was reassembled and used to successfully complete the procedure without reported patient impacts.
Patient Sequence No: 1, Text Type: D, B5
[168590093]
Additional information: udi number, method, results, and conclusions - the returned rod bender was evaluated. Based on the visual evaluation of this device, the tack welds securing the roller to the device fractured, which caused the rollers to disassemble. No other damage was observed. The cause of the fracture can likely be attributed to wear from repeated forces applied during use as well as consistent cleaning/sterilization/processing that could have caused the parts to wear over time. A review of the manufacturing records did not identify any 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
[168590114]
It was reported that when a tray was opened during surgery, the french rod bender was found to be disassembled. It was reassembled and used to successfully complete the procedure without reported patient impacts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012447612-2019-00272 |
| MDR Report Key | 8728475 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-06-24 |
| Date of Report | 2019-11-26 |
| Date of Event | 2019-05-27 |
| Date Mfgr Received | 2019-10-29 |
| Device Manufacturer Date | 2015-06-29 |
| Date Added to Maude | 2019-06-24 |
| 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 | ROD BENDER |
| Generic Name | BENDER |
| Product Code | HXW |
| Date Received | 2019-06-24 |
| Returned To Mfg | 2019-06-14 |
| Model Number | NA |
| Catalog Number | 2000-9044 |
| Lot Number | 703776 |
| 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 | 2019-06-24 |