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 2018-06-13 for LACTOSORB SYSTEM 1.5MM SELF-DRILLING LACTOSORB TAP, DENSE BONE N/A 915-1590-01 manufactured by Biomet Microfixation.
[111441380]
(b)(4). Medical product: biomet microfixation catalog #: 915-2315 lot #: 481170, biomet microfixation battery powered power driver catalog #: 50-1000, biomet microfixation 1. 5mm system power driver battery catalog #: 50-1010 lot #: 723700. Therapy date: (b)(6) 2018. Report source: foreign country - (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. Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00359.
Patient Sequence No: 1, Text Type: N, H10
[111441381]
It was reported the surgeon used the dense bone tap, inserted six screws, and then finished using the heat pen. However, all six screws have come off the bone. The customer believes the incident was caused by the bone tap. There was a twenty minute delay. The patient did not retain a foreign body and the surgery was completed using another device. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00360 |
| MDR Report Key | 7598047 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-06-13 |
| Date of Report | 2018-11-15 |
| Date of Event | 2018-03-29 |
| Date Mfgr Received | 2018-10-16 |
| Device Manufacturer Date | 2016-05-12 |
| Date Added to Maude | 2018-06-13 |
| 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 | LACTOSORB SYSTEM 1.5MM SELF-DRILLING LACTOSORB TAP, DENSE BONE |
| Generic Name | BONE TAP |
| Product Code | HXW |
| Date Received | 2018-06-13 |
| Returned To Mfg | 2018-06-20 |
| Model Number | N/A |
| Catalog Number | 915-1590-01 |
| Lot Number | SEE H10 NARRATIVE |
| ID Number | (01)00841036202170 |
| 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 | 2018-06-13 |