MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-24 for PIP SZ. 20 PROXIMAL PIP-200-20P-WW manufactured by Ascension Orthopedics.
[73731618]
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
[73731619]
It was reported that the surgeon implanted the proximal pip pyro implant. The implant was not fully seated (but close), and he wanted to reposition. When he went to remove the implant to reposition the force of backing it out caused the implant to break. Surgeon removed the remainder of the implant and implanted a new proximal component.
Patient Sequence No: 1, Text Type: D, B5
[75228017]
Integra has completed their internal investigation on april 28, 2017. Results: at this time, the implant has not been returned; therefore, no failure analysis can be performed. If the part is returned, the complaint will be updated accordingly. Dhr review; review of manufacturing records showed no evidence of a nonconformance that may have caused or contributed to the reported event. Complaints history; a trackwise search of the results of the short description field containing? Pip-200-20p? Showed (b)(4) complaints of intra-operative pip fractures and/or breakages, including the report contained in this investigation. From january 2012 to present, there have been (b)(4) pip surgeries performed. This represents a (b)(4) ((b)(4)) overall failure rate which does not represent an adverse trend. Conclusion: as the implant has not been returned to date, no root cause could be determined; however, possible causes include unsupported impacting; incorrect oblique cut or broaching direction; and instrument/tool or method related issues when tried to extract the implant.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2017-00015 |
| MDR Report Key | 6517127 |
| Date Received | 2017-04-24 |
| Date of Report | 2017-03-09 |
| Date of Event | 2017-03-07 |
| Date Mfgr Received | 2017-08-02 |
| Date Added to Maude | 2017-04-24 |
| 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 | 2017-04-24 |
| Returned To Mfg | 2017-06-13 |
| Catalog Number | PIP-200-20P-WW |
| Lot Number | 162035T |
| 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 | 2017-04-24 |