MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-11-13 for PIP SZ. 10 PROXIMAL PIP-200-10P-WW manufactured by Ascension Orthopedics.
[127055459]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[127055460]
It was reported that the implant broke during insertion; the head of the implant was detached from the stem. The reason for surgery was due to a right hand fracture with radius rigidity. The medical staff was able to remove the broken part inside the diaphysis during the procedure with a k-wire, and the removal generated micro particles. It was replaced for another same size implant. The event lead to 30-40 minutes surgical delay with no consequences for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2018-00059 |
| MDR Report Key | 8066147 |
| Report Source | FOREIGN |
| Date Received | 2018-11-13 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-10-18 |
| Date Mfgr Received | 2018-11-05 |
| Date Added to Maude | 2018-11-13 |
| 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 | 3 |
| Brand Name | PIP SZ. 10 PROXIMAL |
| Generic Name | PIP |
| Product Code | NEG |
| Date Received | 2018-11-13 |
| Catalog Number | PIP-200-10P-WW |
| Lot Number | 14-2653 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-11-13 |