MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-04 for TIBIAL IMPACTOR TIP 10203101 manufactured by Ascension Orthopedics.
[141189249]
The tibial impactor tip was not returned for investigation. As such, a failure analysis could not be conducted and a possible root cause could not be found.
Patient Sequence No: 1, Text Type: N, H10
[141189250]
A sales representative reported in behalf of the physician that a tibial impactor tip (id 10203101) broke when impacted and the plastic parts fell in the surgical site. The impactor broke in three small pieces of few mm2 and all broken parts were retrieved. The surgeon had put the 3 broken parts near the rest of the impactor to check that he had the entire impactor. When he saw that the 3 broken parts completed the rest of the impactor as it was originally, he validated that all the broken parts were retrieved. No patient injury was reported and the event did not lead to surgical delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2019-00009 |
| MDR Report Key | 8483556 |
| Date Received | 2019-04-04 |
| Date of Report | 2019-03-06 |
| Date Mfgr Received | 2019-03-06 |
| Date Added to Maude | 2019-04-04 |
| 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 | USER VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | ASCENSION ORTHOPEDICS |
| Manufacturer Street | 8700 CAMERON ROAD #100 |
| Manufacturer City | AUSTIN TX 78754 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TIBIAL IMPACTOR TIP |
| Generic Name | CADENCE TOTAL ANKLE REPLACEMENT SYSTEM |
| Product Code | HXG |
| Date Received | 2019-04-04 |
| Catalog Number | 10203101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS |
| Manufacturer Address | 8700 CAMERON ROAD #100 8700 CAMERON ROAD #100 AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-04 |