MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-10 for THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5 X 4 MM N/A 91-6704 manufactured by Biomet Microfixation.
[132769761]
(b)(4). Device product code: hbw. (b)(4). Report source: foreign country: (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
[132769762]
It was reported the first screw could not go ahead into the patient? S bone because the tip of the screw was not sharp. The second screw fractured after it was inserted into the patient? S bone completely. The surgeon attempted to remove the tip of the screw from the patient? S bone but he/she could not remove it. The surgery was completed using another new screw. Attempts have been made and no further information has been provided. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2019-00028 |
| MDR Report Key | 8235882 |
| Date Received | 2019-01-10 |
| Date of Report | 2019-04-23 |
| Date of Event | 2018-04-13 |
| Date Mfgr Received | 2019-03-26 |
| Device Manufacturer Date | 2018-02-16 |
| Date Added to Maude | 2019-01-10 |
| 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 | 0 |
| Brand Name | THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5 X 4 MM |
| Generic Name | FASTENER, SCREW, CRANIOPLASTY |
| Product Code | HBW |
| Date Received | 2019-01-10 |
| Returned To Mfg | 2019-03-14 |
| Model Number | N/A |
| Catalog Number | 91-6704 |
| Lot Number | 213670 |
| 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. Other | 2019-01-10 |