MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-05-17 for SCANDIMED OPTIGUN II N/A 419300 manufactured by Biomet France S.a.r.l..
[145505564]
(b)(4). Report source, foreign - event occurred in (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. 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
[145505565]
It has been reported that cement gun does not advance beyond approximately 70% resulting in a shortage of cement for implantation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006946279-2019-00265 |
| MDR Report Key | 8619297 |
| Report Source | FOREIGN |
| Date Received | 2019-05-17 |
| Date of Report | 2019-09-17 |
| Date Mfgr Received | 2019-09-16 |
| Device Manufacturer Date | 2017-08-24 |
| Date Added to Maude | 2019-05-17 |
| 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 | SCANDIMED OPTIGUN II |
| Generic Name | DISPENSER, CEMENT |
| Product Code | KIH |
| Date Received | 2019-05-17 |
| Model Number | N/A |
| Catalog Number | 419300 |
| Lot Number | 655433012 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-05-17 |