MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-03-18 for OPTIGUN II 4193 manufactured by Biomet France S.a.r.l..
[139092732]
(b)(4). (b)(6). The device was not returned to the manufacturer. Therefore it could not be analyzed. With the available information, the exact root cause of the event could not be determined. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[139092733]
It has been reported that the gun gears skipped and the cement could not advancing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006946279-2019-00176 |
| MDR Report Key | 8428051 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-03-18 |
| Date of Report | 2019-08-02 |
| Date of Event | 2018-12-19 |
| Date Mfgr Received | 2019-08-01 |
| Device Manufacturer Date | 2018-04-05 |
| Date Added to Maude | 2019-03-18 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | BIOMET FRANCE S.A.R.L. |
| Manufacturer Street | PLATEAU DE LAUTAGNE BP75 |
| Manufacturer City | VALENCE CEDEX 26903 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 26903 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIGUN II |
| Generic Name | DISPENSER, CEMENT |
| Product Code | KIH |
| Date Received | 2019-03-18 |
| Catalog Number | 4193 |
| Lot Number | 665525012 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET FRANCE S.A.R.L. |
| Manufacturer Address | PLATEAU DE LAUTAGNE BP75 VALENCE CEDEX 26903 FR 26903 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-18 |