MAUDE Adverse Event Report: ASCENCION ORTHOPEDICS PIP SZ. 20 PROXIMAL

Catalog Number PIP-200-20P-WW

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2017

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

• Brand Name: PIP SZ. 20 PROXIMAL
• Type of Device: PIP
• Manufacturer (Section D): ASCENCION ORTHOPEDICS; 8700 cameron road; 8700 cameron road; austin TX 78754
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6623673
• MDR Text Key: 77184865
• Report Number: 1651501-2017-00020
• Device Sequence Number: 1
• Product Code: NEG
• Combination Product (y/n): N
• PMA/PMN Number: H010005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PIP-200-20P-WW
• Device Lot Number: 162009T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR