MAUDE Adverse Event Report: NEWDEAL SAS HALLU- FIX ABLATION SET; HALLU-FIX

Catalog Number XXX-HALLU-FIX:

Device Problems Disassembly (1168); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

Foot and ankle international (2010) published: "first metatarsophalangeal arthrodesis using a dorsal plate and a compression screw".Forty-six consecutive cases of first metatarsophalangeal joint fusion were performed using a dorsal plate and a compression screw.The outcome in terms of fusion rate, patient satisfaction and complication rates was analyzed.The 46 feet operated - 36 females and 10 males with an average age of 62 years the average follow up was 23 months.Result: ninety-eight percent of the cases fused uneventfully by four months.Complication: one patient had a superficial wound infection which resolved with oral antibiotics.

Manufacturer Narrative

Integra has completed their internal investigation: as products were not returned, no failure analysis was performed.As dhr review and failure analysis could not be performed, root cause cannot be determined.

• Brand Name: HALLU- FIX ABLATION SET
• Type of Device: HALLU-FIX
• Manufacturer (Section D): NEWDEAL SAS; 97 allee alexandre borodine; 97 allee alexandre borodine; saint priest 69800 ; FR 69800
• Manufacturer (Section G): NEWDEAL SAS; 97 allee alexandre borodine; parc tech de laporte des alpes; saint priest 69800 ; FR 69800
• Manufacturer Contact: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7525247
• MDR Text Key: 108616276
• Report Number: 9615741-2018-00072
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K093781
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-HALLU-FIX:
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other