MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. NEUFLEX MCP IMPLANT SZ 0; FINGER IMPLANT

Catalog Number 123400000

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 04/20/2015

Event Type  Injury  

Event Description

Patient received four neuflex prothesis' about 11 months ago.Today revision as 3 prothesis' are broken and 1 prothesis has a crack.

Manufacturer Narrative

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

Manufacturer Narrative

Additional 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.

Manufacturer Narrative

(b)(4).Examination of the submitted neuflex mcp2 and mcp5 confirmed fracture and cracking due to fatigue cracks that initiated in the corners of the hinges.Due to excessive rubbing of the fracture surfaces, a cause of failure could not be determined for the neuflex mcp4.Examination of the implants¿ fracture surfaces by sem revealed no apparent material defects.Review of supplied x-rays did not provide any information to aid in the determination of the root cause of the implant fractures associated with this complaint.From a medical perspective, based on the very limited information available, it is not possible to determine if the complaint is product related.Review of the device history records and/or a lot specific complaint database search was not possible as the product lot codes required were not provided.The investigation could not verify or identify any product contribution to the reported event with the information provided.The ifu for the product (ifu-0902-00-710) identifies failure of the implant due to fatigue, wear or overloading as an adverse effect and complication.Additionally the warnings and precautions section includes the following information: ¿if excessive loading of the affected finger joint cannot be prevented, a finger joint implant should not be used.¿ 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.25 august 2015 - reopened complaint to update, add product lot codes.A complaint database search finds no additional reports against the provided product and lot combination.The investigation could not verify or identify any product contribution to the reported event with the newly information provided.Based on the inability to identify root cause or evidence of product error as a contributing factor, 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 0
• 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: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4768508
• MDR Text Key: 5949139
• Report Number: 1818910-2015-20630
• 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,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 123400000
• Device Lot Number: 353082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2015
• Date Device Manufactured: 03/12/2013
• 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: 60 YR
• Patient Weight: 72