MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-05-31 for PIP SZ. 20 PROXIMAL PIP-200-20P-WW manufactured by Ascension Orthopedics.
[146666546]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[146666547]
A scrub nurse reported that a pyrocarbon implant (id pip-200-20p-ww - pip sz. 20 proximal) broke up on impaction using the integra impactor specific for the proximal implant. This was removed and replaced with the same product from the implants provided with the loan. All the broken parts were retrieved. No patient injury was reported and the event lead to surgical delay (unknown for how long).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2019-00020 |
| MDR Report Key | 8658765 |
| Report Source | FOREIGN |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-22 |
| Date of Event | 2019-05-18 |
| Date Mfgr Received | 2019-06-25 |
| Date Added to Maude | 2019-05-31 |
| 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. 20 PROXIMAL |
| Generic Name | PIP |
| Product Code | NEG |
| Date Received | 2019-05-31 |
| Returned To Mfg | 2019-06-25 |
| Catalog Number | PIP-200-20P-WW |
| Lot Number | 185336T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-31 |