MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-09-26 for CPLT F&A KIT 3CC 11G SIDE N/A 308.032.2 manufactured by Zimmer Knee Creations, Inc..
[121742662]
During a surgery, it was reported that when the surgeon was removing the cannula, the tip broke off. A trephine drill was then used to remove the broken fragment. The investigation is ongoing, and once additional information becomes available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[121742663]
Cannula tip broken off in patient and was able to be removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2018-00035 |
| MDR Report Key | 7910112 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-26 |
| Date of Report | 2018-12-12 |
| Date of Event | 2018-09-12 |
| Date Mfgr Received | 2018-09-12 |
| Device Manufacturer Date | 2018-07-02 |
| Date Added to Maude | 2018-09-26 |
| 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 | CPLT F&A KIT 3CC 11G SIDE |
| Generic Name | CANNULA |
| Product Code | FGY |
| Date Received | 2018-09-26 |
| Model Number | N/A |
| Catalog Number | 308.032.2 |
| Lot Number | 39237 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-09-26 |