MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-08-09 for 11G ACCUPORT SIDE 120MM N/A 307.032 manufactured by Zimmer Knee Creations, Inc..
[116697163]
After a successful bsm injection, the cannula was left in the femur while post injection scope was performed while the accufill was setting. The cannula was attempted to be removed using a standard power driven wire driver; however, the stylus came out, leaving the cannula behind. The stylus would not reengage, so the cannula was removed manually. In doing so, the tip of the cannula had snapped off and remained in the patient's medial condyle. It was decided to leave the tip in the patient. The cannula was returned and will be investigated as a part of this event. A supplemental report will be submitted upon the completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[116697164]
Reamer snapped off in medial condyle and irretrievable
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2018-00032 |
| MDR Report Key | 7770200 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-09 |
| Date of Report | 2018-09-25 |
| Date of Event | 2018-07-18 |
| Date Mfgr Received | 2018-07-20 |
| Device Manufacturer Date | 2017-03-01 |
| Date Added to Maude | 2018-08-09 |
| 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. SHARI BAILEY |
| Manufacturer Street | 841 SPRINGDALE DRIVE |
| Manufacturer City | EXTON PA 19341 |
| Manufacturer Country | US |
| Manufacturer Postal | 19341 |
| Manufacturer Phone | 4848794543 |
| Manufacturer G1 | ZIMMER KNEE CREATIONS, INC. |
| Manufacturer Street | 841 SPRINGDALE DRIVE |
| Manufacturer City | EXTON PA 19341 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 11G ACCUPORT SIDE 120MM |
| Generic Name | CANNULA |
| Product Code | FGY |
| Date Received | 2018-08-09 |
| Returned To Mfg | 2018-08-06 |
| Model Number | N/A |
| Catalog Number | 307.032 |
| Lot Number | 36471 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 16 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER KNEE CREATIONS, INC. |
| Manufacturer Address | 841 SPRINGDALE DRIVE EXTON PA 19341 US 19341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-09 |