MAUDE Adverse Event Report: NEWDEAL SAS HALLUFIX PLATE, UNKNOWN; HALLU-FIX

Catalog Number XXXPLATE

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

Patient Problem Injury (2348)

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

The journal of foot and ankle surgery (2015) published: "short-term clinical outcome of hemiarthroplasty versus arthrodesis for end-stage hallux rigidus.The primary outcome was patient satisfaction, which was determined using binominal questions.The secondary outcome was treatment failure.The study included 46 patients who had undergone biopro first mtpj hemiarthroplasty and 132 patients who had undergone arthrodesis with integra, new deal hallufix plate.Events: in the arthrodesis group, 5 patients (3.7%) underwent revision arthrodesis at a median time of 19.5 (range 13 to 84) months.The reason for revision was nonunion in all 5 patients.Fifteen arthrodesis patients (11.1%) required a second operation to remove the implant because of pain complaints or infection (it is unknown how many patients had pain and how many patients had infection).Result: no differences were found in the satisfaction rate after a median period of 38.4 (range 12 to 96) months and 39.8 (range 12 to 96) months in the hemiarthroplasty and arthrodesis patients, respectively.Furthermore, no differences were found in the failure rates or the interval to failure.The results of the present study showed no significant differences in the short-term clinical outcomes and failure rates for biopro first mtpj hemiarthroplasty and arthrodesis.Additional information has been requested to the author.

Manufacturer Narrative

Integra has completed their internal investigation: as products were not returned, no failure analysis was performed.As no product id and no manufacturing lot number was provided, no dhr, design specification or design change record will be performed.As dhr review and failure analysis could not be performed, root cause cannot be determined.A review of the current ¿instruction for use nd 01031 (non-sterile) and nd 01831(sterile)¿ was performed.As we can see in paragraph ¿precautions for use¿, conditions like drug, alcohol, smoke addiction and abuse must be taken into account for determine if implant is appropriate for patients.Moreover, ¿bone non-union or delayed union¿, are mentioned as frequent adverse events that could lead into re-operation, revision or removal surgery, arthrodesis of the involved joint, and /or amputation of the limb.In conclusion: postoperative risks and frequent adverse events are mentioned in ifu.

• Brand Name: HALLUFIX PLATE, UNKNOWN
• Type of Device: HALLU-FIX
• Manufacturer (Section D): NEWDEAL SAS; 97 allee alexandre borodine; 97 allee alexandre borodine; saint priest 69800 ; FR 69800
• MDR Report Key: 7570549
• MDR Text Key: 110127887
• Report Number: 9615741-2018-00079
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• 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: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXXPLATE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other