MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-10 for PIP SZ. 30 PROXIMAL PIP-200-30P-WW manufactured by Ascension Orthopedics.
[90311386]
Integra has completed their internal investigation on october 4, 2017. Results: 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 search of the results of the short description field containing? Pip? September 2015 to present showed 11 complaints of intra-operative pip fractures, including this one. (b)(4). Conclusion: the part has not been returned to date; therefore, no root cause can be determined. Possible causes include unsupported impacting and incorrect oblique cut or broaching direction.
Patient Sequence No: 1, Text Type: N, H10
[90311387]
It was reported that the surgeon had successfully implanted both implants during a right and middle finger pip arthroplasty. As he began to assess the range of motion of the implant, the head of the proximal implant (pip-200-30p-ww, lot 163564t) rolled out of the patient with the stem of the implant still embedded. It was reported that this increased surgery time quite dramatically: initially a 70min procedure, the surgery ended up being a 3 hour 40min procedure. Due to breakage, the stem of the implant was difficult to remove, resulting in the additional reaming. This resulted in using larger sized implants: the surgeon resorted to using larger size implants (40p & 30d) that were implanted successfully. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2017-00039 |
| MDR Report Key | 6937209 |
| Date Received | 2017-10-10 |
| Date of Report | 2017-09-20 |
| Date of Event | 2017-09-20 |
| Date Mfgr Received | 2017-09-20 |
| Date Added to Maude | 2017-10-10 |
| 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 | 0 |
| Brand Name | PIP SZ. 30 PROXIMAL |
| Generic Name | PIP |
| Product Code | OMX |
| Date Received | 2017-10-10 |
| Catalog Number | PIP-200-30P-WW |
| Lot Number | 163564T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-10-10 |