MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-06-08 for PIP SZ. 20 PROXIMAL PIP-200-20P-WW manufactured by Ascencion Orthopedics.
[77184865]
Integra has completed their internal investigation on may 31, 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 19 complaints of intra-operative pip fractures and/or breakages, including the report contained in this investigation. Conclusion: from january 2012 to present, there have been 5,767 pip surgeries performed. This represents a 0. 33% (19/5,767) overall failure rate which does not represent an adverse trend.
Patient Sequence No: 1, Text Type: N, H10
[77184866]
It was reported that the implant broke during a pyrocarbon pip arthroplasty. The surgeon had to do an extra hole in the phalanx to introduce a k-wire to contact the tip of the broken stem (which was stuck in the phalanx) to push it out. The event lead to 30 minutes surgical delay removing the broken implant stem. No patient consequences.
Patient Sequence No: 1, Text Type: D, B5
[87033442]
Additional information received on june 13, 2017; the implant broke during impaction. Most probably caused by not broaching fully thereby causing the implant to contact the oblique bone cut before the vertical cut during impaction.
Patient Sequence No: 1, Text Type: N, H10
[114465106]
Integra has completed their internal investigation on may 31, 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 19 complaints of intra-operative pip fractures and/or breakages, including the report contained in this investigation. From (b)(6) 2012 to present, there have been 5,767 pip surgeries performed. This represents a 0. 33% (19/5,767) overall failure rate which does not represent an adverse trend. In addition, review of the complaints shows that the highest severity of complaints is moderate, which does not represent an adverse trend. Conclusion: as the implant has not been returned to date and no additional information has been provided, 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
[119385181]
Integra has completed their internal investigation on july 11, 2017. Results: evaluation of returned device; the complaint part was received in two pieces. Based on the visual analysis performed under the microscope, the failure mode of the part could not be discerned; however, the fracture appearance is consistent with a rapid brittle, bending fracture. Stem fractures are known to occur upon impact used to seat the prosthesis during surgical implantation into an incompletely broached medullary canal. Conclusion: while the part was returned and failure was confirmed, no root cause could be determined. Possible causes include unsupported impacting and incorrect oblique cut or broaching direction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2017-00020 |
| MDR Report Key | 6623673 |
| Report Source | FOREIGN |
| Date Received | 2017-06-08 |
| Date of Report | 2017-05-17 |
| Date of Event | 2017-05-17 |
| Date Mfgr Received | 2017-07-11 |
| Date Added to Maude | 2017-06-08 |
| 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 | 2017-06-08 |
| Returned To Mfg | 2017-07-07 |
| Catalog Number | PIP-200-20P-WW |
| Lot Number | 162009T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENCION ORTHOPEDICS |
| Manufacturer Address | 8700 CAMERON ROAD 8700 CAMERON ROAD AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-06-08 |