MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS PIP SZ. 30 PROXIMAL

Catalog Number PIP-200-30P-WW

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2017

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: PIP SZ. 30 PROXIMAL
• Type of Device: PIP
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; 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: 6937209
• MDR Text Key: 90311386
• Report Number: 1651501-2017-00039
• Device Sequence Number: 1
• Product Code: OMX
• Combination Product (y/n): N
• PMA/PMN Number: H010005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PIP-200-30P-WW
• Device Lot Number: 163564T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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