MAUDE Adverse Event Report: SMALL BONE INNOVATIONS, INC. SUTTER PROXIMAL INTERPHALAGEAL JOINT; SILICONE PIP IMPLANT

Model Number PIP-20

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 04/25/2014

Event Type  Injury  

Event Description

Two silicone pip implants were removed due to implant fracture.

Manufacturer Narrative

Additional removed components: model #: pip-10.Lot #: 22708102.Exp date: 07/30/2016.Device mfr date: 07/01/2011.Visual examination confirms both implants are fractured.The cause of implant fracture is unknown.There were no deviations reported in the dhrs for part numbers pip-20, lot 22708202 and pip-10, lot 22708102.All released parts were within specification.

• Brand Name: SUTTER PROXIMAL INTERPHALAGEAL JOINT
• Type of Device: SILICONE PIP IMPLANT
• Manufacturer (Section D): SMALL BONE INNOVATIONS, INC.; morrisville PA
• Manufacturer Contact: steve ward ; 1380 s. pennsylvania ave.; morrisville, PA 19067 ; 2153376381
• MDR Report Key: 4024242
• MDR Text Key: 4879863
• Report Number: 3003640913-2014-00057
• Device Sequence Number: 1
• Product Code: KYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2016
• Device Model Number: PIP-20
• Device Lot Number: 22708202
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR