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 2018-06-19 for PECTUS TABLE TOP BENDER N/A 01-3906 manufactured by Biomet Microfixation.
[112302922]
(b)(4). 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
[112302923]
It was reported the table top bender broke in the middle of surgery while the doctor was trying to bend the bar. The procedure was a minimally invasive repair of pectus carinatum (abhramson technique). The surgeon bent the template and contoured it to the patient, he took the template and pulled out the corresponding pectus bar and began the process of bending the bar. The bender was working quite well, he got about a fifth of the way across the bar and was making the next bend and nothing happened. He pumped again and nothing happened for a second pump of the bar, he attempted a third time and the handle of the bender proceeded to snap off. He then tried the hand held benders within the tray, however this case was later in the day and he had already done a different surgical procedure earlier in the day and his hands were feeling fatigued and he was not having a ton of success with the handheld bender as the bar is so tough. He proceeded to ask the circulating nurse for another table top bender from an ortho tray somewhere else on the floor, the nurse returned about ten minutes later and he finished the bend portion of the case with the ortho bender. The incident caused 10-15 minutes to be added to the overall time of the surgery. The surgeon looked at the broken parts and thought they looked like they must have been fatigued prior to his use, and almost thought they had been welded back together at some point. He stated if you look at the crack, it did not appear to be a simple break, it looked like it might have had previous fatigue and maybe even a previous repair had been attempted. The case was completed with great success, and the patient actually left the hospital within three days, and is doing well. No adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00384 |
| MDR Report Key | 7614711 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-06-19 |
| Date of Report | 2018-11-30 |
| Date of Event | 2018-05-22 |
| Date Mfgr Received | 2018-11-27 |
| Device Manufacturer Date | 2013-04-29 |
| Date Added to Maude | 2018-06-19 |
| 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 | BENDER |
| Product Code | HXW |
| Date Received | 2018-06-19 |
| Returned To Mfg | 2018-11-27 |
| Model Number | N/A |
| Catalog Number | 01-3906 |
| Lot Number | 042513C13 |
| ID Number | (01)00841036011239 |
| Operator | PHYSICIAN |
| 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 | 2018-06-19 |