MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-20 for ACCUPORT N/A 514.502 manufactured by Zimmer Knee Creations, Inc..
[80621068]
The investigator called the sales rep that was present at the case, (b)(6), to review the actions that lead up to this failure. (b)(6) indicated that he was in the room at the time and that the case had proceeded fairly normally; exceptions being that the stylus could not be fully inserted and the breakage occurred. There was no indication of particularly hard bone nor did the cannula need to be re-directed. Neither (b)(6) nor the surgeon had any indication that the cannula had broken until it was removed from the patient. After the cannula was removed, the piece could be seen via the c-arm as remaining inside the body. The surgeon did not attempt to retrieve it. A review of the risk document for this product shows that the failure mode has already been documented. As for the potential causes of that failure mode, one is considered acceptable based on the occurrence rate, and the remaining three are undesirable. Those undesirable results are cleared as a result of the attached clinical risk assessments (cra). The dhr was reviewed and no abnormalities were identified. A retain was also pulled and examine. Upon visual inspection, the retain did not show any signs of abnormality. The surgeon stated that he drilled in the accuport? Cannula, proceeded to inject the accufill? Bsm, plunged with the stylus, and left the accufill? Bsm to harden before removing the cannula (all with the knee in a bent hanging position). While the accufill? Bsm was hardening, dr. (b)(6) did begin to perform the arthroscopic part of the procedure and articulate the leg to almost full extension. The nurse practitioner reported that she heard a? Pop? At that stage of the procedure, but no one else can confirm that. After removing the accuport? Cannula, the surgeon took the c-arm image and learned of the breakage. (b)(6) commented that the stylus was not fully engaged for the removal of the instrument. Dr. (b)(6) then completed the arthroscopic part of the procedure. The surgeon indicated that the point of fracture was? Deep? Within the bone, not near the cancellous bone. The accuport? Cannula was returned to zimmer knee creations for examination. Please see attached report? Instrument review for (b)(4) - for that evaluation. After completing this investigation, no conclusion can be definitively drawn regarding how the failure occurred. The events as they were reported do not give a clear indication of when the breakage occurred, nor does the instrument give a clear indication of where the bending or torsional force came from. While it is apparent from the returned part that the instrument experienced excessive bending and/or torsional force, it cannot be determined what events lead to that.
Patient Sequence No: 1, Text Type: N, H10
[80621069]
Cannula section broke and remained inside patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2017-00018 |
| MDR Report Key | 6730093 |
| Date Received | 2017-07-20 |
| Date of Report | 2017-07-20 |
| Date of Event | 2017-06-28 |
| Date Mfgr Received | 2017-07-06 |
| Device Manufacturer Date | 2017-04-05 |
| Date Added to Maude | 2017-07-20 |
| 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 | ACCUPORT |
| Generic Name | CANNULA |
| Product Code | FGY |
| Date Received | 2017-07-20 |
| Model Number | N/A |
| Catalog Number | 514.502 |
| Lot Number | KC04045 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-07-20 |