MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-04 for ITOTAL IDENTITY CR ED-07827 manufactured by Conformis, Inc..
[181956622]
It was reported that the locking button would not engage the keel punch on the itotal identity impactor handle. The spring inside the impactor handle would not hold onto the keel punch causing it to not function properly. There was no patient impact or major delays in surgery. Inspection of the device did yield a definite cause for the device malfunction. Review of the device history record indicates that the device was manufactured to specification.
Patient Sequence No: 1, Text Type: N, H10
[181956623]
It was reported that the locking button would not engage the keel punch on the itotal identity impactor handle. The spring inside the impactor handle would not hold onto the keel punch causing it to not function properly. There was no patient impact or major delays in surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004153240-2020-00024 |
| MDR Report Key | 9665396 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-01-10 |
| Date Added to Maude | 2020-02-04 |
| 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 | EMMANUEL NYAKAKO |
| Manufacturer Street | 600 TECHNOLOGY PARK DRIVE |
| Manufacturer City | BILLERICA MA 01821 |
| Manufacturer Country | US |
| Manufacturer Postal | 01821 |
| Manufacturer Phone | 7813459164 |
| Manufacturer G1 | CONFORMIS, INC. |
| Manufacturer Street | 600 RESEARCH DRIVE |
| Manufacturer City | WILMINGTON MA 01887 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01887 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ITOTAL IDENTITY CR |
| Generic Name | TOTAL KNEE REPLACEMENT SYSTEM |
| Product Code | OOG |
| Date Received | 2020-02-04 |
| Returned To Mfg | 2020-01-15 |
| Model Number | ED-07827 |
| Lot Number | G190901 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONFORMIS, INC. |
| Manufacturer Address | 600 TECHNOLOGY PARK DRIVE BILLERICA MA 01821 US 01821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-04 |