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 2018-01-08 for CARROLL-GIRARD SCREW HEX-END N/A SP-2693 manufactured by Biomet Microfixation.
[96636544]
(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
[96636545]
It was reported "the screw fractured during zygomatic fracture reduction. The tip of the remained screw in the patient? S bone was removed using other device. The surgery was completed using a u type hook and the delay was less than 20 minutes. " the following contributing factor related to the event was reported, "the surgeon pulled a screw obliquely in the strong force during procedure. " no additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00015 |
| MDR Report Key | 7172312 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-01-08 |
| Date of Report | 2018-06-29 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2018-06-13 |
| Device Manufacturer Date | 2014-10-20 |
| Date Added to Maude | 2018-01-08 |
| 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 | CARROLL-GIRARD SCREW HEX-END |
| Generic Name | CORKSCREW |
| Product Code | HWI |
| Date Received | 2018-01-08 |
| Returned To Mfg | 2018-01-16 |
| Model Number | N/A |
| Catalog Number | SP-2693 |
| Lot Number | 566220 |
| ID Number | (01)00841036145491 |
| 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 | 1. Required No Informationntervention | 2018-01-08 |