MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. NEUFLEX MCP IMPLANT SZ 30; FINGER IMPLANT

Catalog Number 123430000

Device Problem Fracture (1260)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 03/23/2016

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Surgeon reported fracture of prothesis.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Update rec'd 18 april 2016 - the patient's medical records were received.Medical records were reviewed for mdr reportability.According to the medical records, upon revision the prosthesis fragment was found in the upper recess of the joint capsule.Upon revision a silicon synovitis was encountered.At this time there is no new information that would change the existing mdr decision.The complaint was updated on: 16 may 2016.

Manufacturer Narrative

Conclusion and justification status for mdr: examination of the submitted device confirmed the reported fracture.Fracture of the finger component is consistent with reversed bending fatigue fracture.The repetitive loading of the finger component, in both flexion and extension, exceeded the fatigue limit of the material resulting in fatigue fracture.No evidence of material or manufacturing defects was observed.A worldwide complaint database search found no additional related reports against the complaint sample product code/lot code combination.The investigation did not find any evidence indicating product error was a contributing factor to the reported event and the need for corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: NEUFLEX MCP IMPLANT SZ 30
• Type of Device: FINGER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5570473
• MDR Text Key: 42422371
• Report Number: 1818910-2016-17205
• Device Sequence Number: 1
• Product Code: KYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK970544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 123430000
• Device Lot Number: 135348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2011
• 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: 54 YR
• Patient Weight: 69