MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-02-12 for PIP SZ. 20 PROXIMAL PIP-200-20P-WW manufactured by Ascension Orthopedics.
[100040338]
Integra has completed their internal investigation on february 1, 2018. Dhr review; no defects were noted in the dhr review that may have contributed to this complaint. Complaints history; a trackwise search of the results of the short description field containing? Pip? November 2015 to present showed 13 complaints of intra-operative pip fractures, including this one. During this period of time, there have been 3,449 pip surgeries performed. This represents 0. 377% (13/3,449) overall failure rate. Not an adverse trend. Conclusion: the root cause of the reported event is unknown. As the device has not been returned, the root cause of the report cannot not be confirmed to date. In the past, similar issues that resulted in intra-operative pip fractures have been attributed to improperly prepared oblique osteotomy, improper placement of the implant (e. G. , impacting unsupported head with too much force), or improper implant size selection.
Patient Sequence No: 1, Text Type: N, H10
[100040339]
It was reported that the implant broke in 3 pieces during the procedure. The surgery was completed with a replacement implant. No patient injury or consequences and the event did not lead to surgical delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2018-00009 |
| MDR Report Key | 7263072 |
| Report Source | FOREIGN |
| Date Received | 2018-02-12 |
| Date of Report | 2018-02-01 |
| Date of Event | 2018-01-31 |
| Date Mfgr Received | 2018-03-20 |
| Device Manufacturer Date | 2016-12-28 |
| Date Added to Maude | 2018-02-12 |
| 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 SONIA IRIZARRY |
| 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 | 2018-02-12 |
| Returned To Mfg | 2018-02-28 |
| Catalog Number | PIP-200-20P-WW |
| Lot Number | 163848T |
| 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 | 2018-02-12 |