MAUDE Adverse Event Report: IN2BONES USA RTS FLEXIBLE 1AT MPJ IMPLANT; RTS REFERENCE TOE

Model Number M30 SE010

Device Problem Material Fragmentation (1261)

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

Event Date 08/09/2019

Event Type  malfunction  

Manufacturer Narrative

Product was returned to manufacturer for evaluation.Evaluation showed that the implant appeared to have broken some time ago and as a result had become smoothed out over time.No conclusive root cause for the event could be identified.

Event Description

It was reported that the implant broke at an unknown time post-op.The break was discovered approximately 3 years after initial implant date.Patient was revised and a new implant was implanted.No further details are known at this time.

• Brand Name: RTS FLEXIBLE 1AT MPJ IMPLANT
• Type of Device: RTS REFERENCE TOE
• Manufacturer (Section D): IN2BONES USA; 6000 poplar ave; suite 115; memphis TN 38119
• Manufacturer (Section G): IN2BONES USA; 6000 poplar ave; suite 115; memphis TN 38119
• Manufacturer Contact: cristi mann ; 6000 poplar ave; suite 115; memphis, TN 38119 ; 9012607931
• MDR Report Key: 8969779
• MDR Text Key: 205005379
• Report Number: 3011580264-2019-00015
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2023
• Device Model Number: M30 SE010
• Device Lot Number: 9G0HM0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 3 YR
• Event Location: Hospital
• Date Manufacturer Received: 08/09/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR