MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2018-11-07 for PECTUS BAR BENDER N/A 01-3905 manufactured by Biomet Microfixation.
[126363998]
(b)(4). Lot number: there are five possible lot numbers: 372900; 307010; 914170; 446890; 308560. Unique identifier (udi) number: (b)(4). (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[126363999]
It was reported "one of gripping-pin, used for pinching header portion, broke during the procedure. It happened when the surgeon was going to bend the pectus bar, because the necessity for the procedure. " there was a delay between thirty minutes to one hour due to two issues, "the drop off of the bar from patient body by the breakage of bender instrument. As a result it had to re-autoclave urgently. Second was making certain alternative bender arrangement. " the distributor reported the bender has been consigned over 200 times. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00747 |
| MDR Report Key | 8045658 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-11-07 |
| Date of Report | 2019-01-23 |
| Date of Event | 2018-09-20 |
| Date Mfgr Received | 2019-01-08 |
| Device Manufacturer Date | 2013-08-20 |
| Date Added to Maude | 2018-11-07 |
| 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 BAR BENDER |
| Generic Name | BENDER |
| Product Code | HXW |
| Date Received | 2018-11-07 |
| Returned To Mfg | 2018-10-15 |
| Model Number | N/A |
| Catalog Number | 01-3905 |
| Lot Number | SEE H10 NARRATIVE |
| 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 | 1. Hospitalization | 2018-11-07 |