MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-03-15 for OPTIGUN RATCHET 4195 manufactured by Biomet France S.a.r.l..
[139220747]
(b)(4). Report source, foreign - event occurred in (b)(6). The device was not evaluated as the batch number was not communicated and the product was not returned. The device was not returned to the manufacturer. Therefore it could not be analyzed. The device manufacturing quality record could not be reviewed as the lot number of the product were not communicated. 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. Lot number not communicated.
Patient Sequence No: 1, Text Type: N, H10
[139220748]
It has been reported that the gun handle is not returning to the? Open? Position after a squeeze cycle. It is as if the spring is not strong enough.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006946279-2019-00172 |
| MDR Report Key | 8424036 |
| Report Source | FOREIGN |
| Date Received | 2019-03-15 |
| Date of Report | 2019-03-14 |
| Date of Event | 2018-12-03 |
| Date Mfgr Received | 2018-12-03 |
| Date Added to Maude | 2019-03-15 |
| 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 RATCHET |
| Generic Name | DISPENSER, CEMENT |
| Product Code | KIH |
| Date Received | 2019-03-15 |
| Catalog Number | 4195 |
| Lot Number | NOT COMMUNICATED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-03-15 |