MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS SILICONE PIP SZ. 1

Catalog Number SPIP-520-1-WW

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Dhr - review of manufacturing records for spip-520-1-ww cmr 163711t showed no evidence of a nonconformance that may have caused or contributed to the reported event.Failure analysis - the device in question has not been returned to date.Images of the explanted spip were provided showing the device in two pieces, separated at the hinge, confirming the reported event.Root cause - based on the information received to date, the root cause is undetermined.The event may be due to trauma or an improperly seated implant leading to additional stress on the hinge may have caused or contributed to the event.

Event Description

On (b)(6) 2017 a silicone pip (id spip-520-1-ww - silicone pip sz.1) was implanted due to a bouchard's node with pain.During a regular follow-up visit on (b)(6) 2019, the patient complained that the finger had become difficult to extend and on (b)(6) 2019 the implant was removed by revision surgery due to an early fracture of the hinge.There is no information about other traumatic events.

• Brand Name: SILICONE PIP SZ. 1
• Type of Device: SILICONE 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: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8875563
• MDR Text Key: 153798929
• Report Number: 1651501-2019-00029
• Device Sequence Number: 1
• Product Code: KYJ
• Combination Product (y/n): N
• PMA/PMN Number: K082231
• 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: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SPIP-520-1-WW
• Device Lot Number: 163711T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2019
• 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