MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-08-17 for PECTUS TABLE TOP BENDER N/A 01-3906 manufactured by Biomet Microfixation.
[117430700]
(b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[117430701]
It was reported the pectus bar bender did not work when the distributor tested it. When pushing the handle the piston did not engage or move, therefore the bar would not have been able to be bent. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00555 |
| MDR Report Key | 7792621 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-08-17 |
| Date of Report | 2019-01-09 |
| Date Mfgr Received | 2018-12-14 |
| Device Manufacturer Date | 2015-02-23 |
| Date Added to Maude | 2018-08-17 |
| 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 | MRS. MICHELLE COLE |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| Manufacturer G1 | BIOMET MICROFIXATION |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32218 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PECTUS TABLE TOP BENDER |
| Generic Name | PECTUS BAR BENDER |
| Product Code | HXW |
| Date Received | 2018-08-17 |
| Returned To Mfg | 2018-08-07 |
| Model Number | N/A |
| Catalog Number | 01-3906 |
| Lot Number | 012815L14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATION |
| Manufacturer Address | 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-17 |