MAUDE Adverse Event Report: ARTHREX DISSOLVABLE PINS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

The arthrex trim it pins, used in hammer toe surgery in 2011, did not dissolve, as they were supposed to.The result has been ongoing pain, for 3 years.No that this has been discovered, as i went for pain relief consultation, an additional surgery has been scheduled.

• Brand Name: DISSOLVABLE PINS
• Type of Device: DISSOLVABLE PINS
• Manufacturer (Section D): ARTHREX
• MDR Report Key: 3872178
• MDR Text Key: 4455700
• Report Number: MW5036558
• Device Sequence Number: 1
• Product Code: HTY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 84