MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-05-16 for 1.5 LACTOSORB SYSTEM 1.5 X 4 MM DIRECT DRIVE LACTOSORB SCREW N/A 915-2215 manufactured by Biomet Microfixation.
[108416522]
(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
[108416523]
It was reported the part broke "during the operation of the upper screw. " attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[117480486]
This follow-up report is being submitted to relay additional information.
Patient Sequence No: 1, Text Type: N, H10
[117480487]
It was reported the screws fractured at or near the head of the screw. The surgeon replaced the broken screws. There was a five minute delay. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00275 |
| MDR Report Key | 7518938 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-05-16 |
| Date of Report | 2018-10-31 |
| Date of Event | 2017-08-29 |
| Date Mfgr Received | 2018-10-11 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2018-05-16 |
| 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 | 1.5 LACTOSORB SYSTEM 1.5 X 4 MM DIRECT DRIVE LACTOSORB SCREW |
| Generic Name | BONE SCREW |
| Product Code | NHB |
| Date Received | 2018-05-16 |
| Returned To Mfg | 2018-08-22 |
| Model Number | N/A |
| Catalog Number | 915-2215 |
| Lot Number | 700710 |
| ID Number | N/A |
| Device Expiration Date | 2019-12-01 |
| 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 | 2018-05-16 |