MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS NAIL, 10MM X 150MM; PANTA2

Catalog Number PAN-1010-10150

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).A review of the lot records was conducted.A non-conformance was initiated to address a discrepancy between the revisions at which the product lot was ordered and manufactured.The evaluation determined that the product lot was manufactured to the current revision and that there was no impact to product quality.There were no indications that the non-conformance could have caused or contributed to the complaint.The part was not returned to integra for investigation, but x-ray images were provided.Evaluation of the provided x-ray images showed that the nail appeared to be fractured into two pieces.The failure was confirmed.As the implant has not yet been returned, a definitive root cause cannot be determined.According to a previous similar complaint, potential causes for the failure included premature and excessive loading of the implant.The panta2 instructions for use state that the panta implants ¿are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.Load bearing or weight bearing in the presence of a delayed union or non-union may eventually contribute to or cause implant breakage¿.If the part is later returned, this complaint may be reopened and further investigation conducted.

Event Description

A physician reported the panta 2 nail broke distal to lowest oblong hole during a tcc fusion procedure.No further information is available.

• Brand Name: NAIL, 10MM X 150MM
• Type of Device: PANTA2
• 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: vivian nelson ; 1000 campus drive; princeton, NJ 08536 ; 6099362319
• MDR Report Key: 10653560
• MDR Text Key: 226108553
• Report Number: 1651501-2020-00018
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K181639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PAN-1010-10150
• Device Lot Number: 185207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2020
• 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