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 2019-03-11 for OPTIGUN II 4193 manufactured by Biomet France S.a.r.l..
[138432816]
(b)(4). The investigation is ongoing a supplemental will be provided to share the investigation results.
Patient Sequence No: 1, Text Type: N, H10
[138432817]
It has been reported that due to frequent material use, it probably came to the breakage of the gun.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006946279-2019-00170 |
| MDR Report Key | 8408835 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-03-11 |
| Date of Report | 2019-07-18 |
| Date of Event | 2018-09-04 |
| Date Mfgr Received | 2019-07-17 |
| Date Added to Maude | 2019-03-11 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIGUN II |
| Generic Name | DISPENSER, CEMENT |
| Product Code | KIH |
| Date Received | 2019-03-11 |
| Returned To Mfg | 2018-09-13 |
| Catalog Number | 4193 |
| Lot Number | 2059401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-03-11 |