MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-08-13 for OPTIGUN II 4193 manufactured by Biomet France S.a.r.l..
[116869268]
(b)(4). The device was not yet returned to the manufacturer. Therefore it could not be analyzed. The device manufacturing quality record indicates that the released product met all requirements to perform as intended. 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
[116869269]
It was reported that the gun was misfiring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006946279-2018-00304 |
| MDR Report Key | 7776319 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-08-13 |
| Date of Report | 2018-08-10 |
| Date of Event | 2018-07-04 |
| Date Mfgr Received | 2018-07-26 |
| Device Manufacturer Date | 2012-09-14 |
| Date Added to Maude | 2018-08-13 |
| 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 | MS. H BATAILLE |
| Manufacturer Street | PLATEAU DE LAUTAGNE BP75 |
| Manufacturer City | VALENCE 26903 |
| Manufacturer Country | FR |
| Manufacturer Postal | 26903 |
| Manufacturer Phone | 0334757591 |
| 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 | 2018-08-13 |
| Returned To Mfg | 2018-09-24 |
| Catalog Number | 4193 |
| Lot Number | 0000765723 |
| 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 FRANCE S.A.R.L. |
| Manufacturer Address | PLATEAU DE LAUTAGNE BP75 VALENCE CEDEX 26903 FR 26903 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-13 |