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 FRENCH ROD BENDER 07.02092.001 manufactured by Zimmer Biomet Spine Inc..
[144962385]
Udi number: (b)(4). The returned rod bender was evaluated. One of the pivot screws has fractured, preventing the device from being able to bend a rod. The cause is likely attributed to repetitive usage and high strength applications associated with bending cocr rods. A review of the manufacturing records did not identify any issues that would have contributed to this event. Reference report 3012447612-2019-00220.
Patient Sequence No: 1, Text Type: N, H10
[144962386]
It was reported that two french rod benders were stiff during surgery. Upon evaluation at zimmer biomet spine, one bender was found to be missing a set screw in the center knob, and the other has a broken dowel pin. Another rod bender was used to complete the procedure without reported patient impacts. This is report two of two for this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012447612-2019-00221 |
| MDR Report Key | 8607559 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-05-14 |
| Date of Report | 2019-05-14 |
| Date of Event | 2019-01-08 |
| Date Mfgr Received | 2019-04-19 |
| Device Manufacturer Date | 2016-04-01 |
| 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 | FRENCH ROD BENDER |
| Generic Name | BENDER |
| Product Code | HXW |
| Date Received | 2019-05-14 |
| Returned To Mfg | 2019-02-18 |
| Model Number | NA |
| Catalog Number | 07.02092.001 |
| Lot Number | 63028554 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 |