MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-02-16 for ACCUPORT END DELIVERY N/A 308.034.2 manufactured by Zimmer Knee Creations, Inc..
[67614949]
The investigation on this complaint is still on going and therefore not been complete. There will be a supplemental mdr following this initial mdr submission once the investigation is completed. Device not returned at this time.
Patient Sequence No: 1, Text Type: N, H10
[67614950]
Broken cannula was removed from patient.
Patient Sequence No: 1, Text Type: D, B5
[73478953]
Further investigation was conducted with the surgeon and sales rep present during the case. The patient is large athletic type with hard high density bone in the talus. Surgery was conducted in the talus where the end delivery cannula was drilled up into bone for delivery of the bone void filler. After injection and some time during set up of the material, the surgeon attempted to remove the cannula from the talus by hand. The tip of cannula broke inside the talus during removal; the surgeon was able to retrieve the fragment from the bone using a reverse drill bit. The broken fragment and cannula were returned for further analysis. Upon analysis it was evident that the stylus of the cannula was not fully seated into the cannula during the removal process - both the fragment and the cannula were occluded with hardened bsm material that had not been cleared with normal insertion of the stylus. Thus during the removal the cannula was unsupported by the inner stylus. The fracture occured at the weakest point in the cannula where the threading starts. At the fracture site flared metal could be seen which can be evident of extreme bending of the cannula leading to fracture. This bending fracture could occur in an unsupported cannula being removed without support of the stylus. The ifu of the cannula states warning not to bend the cannula, not to remove by hand, and not to remove the cannula without the stylus. The fracture occurred due to not following those warnings and due to the excessive forces placed on the cannula due to incorrect assembly of the cannula before removal.
Patient Sequence No: 1, Text Type: N, H10
[73478954]
Broken cannula was removed from patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2017-00008 |
| MDR Report Key | 6337143 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-02-16 |
| Date of Report | 2017-03-30 |
| Date of Event | 2017-01-16 |
| Date Mfgr Received | 2017-01-17 |
| Date Added to Maude | 2017-02-16 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | ACCUPORT END DELIVERY |
| Generic Name | CANNULA |
| Product Code | FGY |
| Date Received | 2017-02-16 |
| Model Number | N/A |
| Catalog Number | 308.034.2 |
| Lot Number | 34887 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-02-16 |