MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS SILICONE PIP SZ. 2

Catalog Number SPIP-520-2-WW

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.Review of manufacturing records showed no evidence of a nonconformance that may have caused or contributed to the reported event.Based on the information received to date, the root cause cannot be determined nor can the failure be confirmed.The initial report states that the patient was flicking a book page, and the relationship of this event to the break cannot be determined.Outside of patient trauma, an improperly seated implant leading to additional stress on the hinge may have caused or contributed to the event.

Event Description

It was reported that a spip-520-2-ww silicone pip implant broke.In (b)(6) 2016, a pip j replacement in the index finger was performed with a spip-520-2-ww silicone pip implant.In (b)(6) 2018, 17 months post implantation, the implant broke while the patient was flicking the page of a book.No specific trauma or contributing events prior to the discovery of the issue.Subsequently, the implanted product was explanted and was replaced with another of the same size.No further patient complications were reported and the patient was doing well after the procedure.Additional information was requested.

Manufacturer Narrative

The device in question was returned to ils-austin.As received, the device was observed to be in two separate pieces, confirming the failure.Based on the information and failure analysis received to date, the failure is confirmed.However, the root cause cannot be determined.

Manufacturer Narrative

The device in question was returned to ils-austin.As received, the device was observed to be in two separate pieces, confirming the failure.Additional analysis was later performed.Visual examination aided with a stereomicroscope revealed a tear across the web in the implant hinge.Fracture topography indicated a bending overload tear fracture.The web tear is consistent with bending overload.Also, the web of the hinge has the smallest cross section and is the typical location of failures in the silicone implants.Based on the information and failure analysis received to date, the failure is confirmed.However, the root cause cannot be determined.The initial report states that the patient was flicking a book page, and the relationship of this event to the break cannot be determined.Outside of patient trauma, an improperly seated implant leading to additional stress on the hinge may have caused or contributed to the event.

• Brand Name: SILICONE PIP SZ. 2
• 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 ; 105 morgan lane; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7370698
• MDR Text Key: 103465285
• Report Number: 1651501-2018-00022
• 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,foreig
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SPIP-520-2-WW
• Device Lot Number: 151016T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2018
• 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: 77 YR