MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-12-14 for K2 HEMI TOE IMPLANT SYSTEM 20-1020 manufactured by Kinetikos Medical Inc..
[554664]
Explant of a katalyst radial head system implant from the patient immediately (during original implantation) upon determining that the implant's expiration date had elapsed six weeks previously. The explanted component was returned to kmi for evaluation on dec. 12, 2006. In 2006, kinetikos medical, inc. , was informed of a k2 hemi toe with expired labeling that was inadvertently implanted into a patient, then immediately removed and replaced (within minutes) when this discovery was made. The explanted device was returned to kmi on dec. 12, 2007 for confirmation of lot number and expiration status.
Patient Sequence No: 1, Text Type: D, B5
[8052455]
It was ultimately determined that this particular implant lot, technically had an additional 2 years of shelf life beyond its labeling indications, owing to testing performed during the interval between its production date (september, 2003) and its implant date. As this particular implant had not been returned to kmi from field consignment since this testing was completed, it was never re-labeled with the extended expiration dating allowed. Therefore, there is no clinical implication to the patient of its having been implanted. Identifying the root cause - owing to unfamiliarity with the kinetikos medical product lines, the k2 hemi toe inventory was the only sterile implant group not originally programmed in the distribution centers' database as being shelf-life sensitive. Product from kmi's warehouse and field consignment inventory with limited remaining shelf life had begun to be shipped to and stored in september, 2006, and was therefore subject to distribution as needed. Corrective/preventative action - since the advent of this event, two first-line corrective and preventive actions have been put into place which will preclude a recurrence of this nature: the source of sterile implants has inventoried all sterile implants (including all k2 hemi toe), isolated those that will expire by the end of february, 2007, and quarantined or destroyed them. Inventorying and purging of all products due to expire within the next 90 days will be performed at kmi on a rolling monthly basis until these operations permanently move off-site (currently scheduled for january, 2007). The inventory control system at the distribution center has now been programmed to automatically flag any inventory due to expire within the next 90 days, including k2 hemi toes. Once identified, those materials will be quarantined by qc personnel, and returned to kinetikos medical, inc. For final dispositioning. Risk assessment - given the systemic corrective and preventive actions that have now been implemented at both the inventory origin and distribution centers, the risk of distributing any expired (actual, or as labeled) sterile implants have virtually been eliminated. Post-market surveillance - of the 1,875+ k2 hemi toe implants that have been implanted since this products' initial release in 2002, this is only the second reportable incident on record, demonstrating this systems reliability, safety and effectiveness. Post-market surveillance of the k2 hemi toe system is on-going; all sources and types of product information will be taken into consideration, reviewed and documented by kmi management per qsp-157.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028840-2006-00024 |
| MDR Report Key | 795565 |
| Report Source | 07 |
| Date Received | 2006-12-14 |
| Date of Report | 2006-12-12 |
| Date of Event | 2006-11-14 |
| Date Mfgr Received | 2006-12-12 |
| Device Manufacturer Date | 2003-09-01 |
| Date Added to Maude | 2006-12-20 |
| 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 | 0 |
| Manufacturer Street | 6005 HIDDEN VALLEY RD SUITE #180 |
| Manufacturer City | CARLSBAD CA 92011 |
| Manufacturer Country | US |
| Manufacturer Postal | 92011 |
| Manufacturer Phone | 7604481706 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K2 HEMI TOE IMPLANT SYSTEM |
| Generic Name | ORTHOPEDIC TOE IMPLANT |
| Product Code | LZJ |
| Date Received | 2006-12-14 |
| Returned To Mfg | 2006-12-12 |
| Model Number | 20-1020 |
| Catalog Number | 20-1020 |
| Lot Number | 7894-20-8224 |
| ID Number | * |
| Device Expiration Date | 2006-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 783143 |
| Manufacturer | KINETIKOS MEDICAL INC. |
| Manufacturer Address | * CARLSBAD CA 92011 US |
| Baseline Brand Name | K2 HEMI TOE IMPLANT SYSTEM |
| Baseline Generic Name | ORTHOPEDIC TOE IMPLANT |
| Baseline Model No | 20-1020 |
| Baseline Catalog No | 20-1020 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-12-14 |