MAUDE Adverse Event Report: NEWDEAL SAS PANTA NAIL SCREW - UNSPECIFIED; N/A

Catalog Number XXX-PANTA NAIL SCREW

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 06/11/2015

Event Type  Injury  

Event Description

It was reported a patient underwent revision surgery due to the device breaking.The reporting surgeon was contacted by another surgeon for a referral of a failed panta nail case with 2 broken calcaneal screws.The reporting surgeon requested assistance from integra to remove the nail for which a panta nail removal set and normal panta nail set was needed and sent to the hospital.The revision surgery took place on (b)(6) 2015.X-rays confirmed breakage and showed positioning of the nails.The surgery was expectedly very difficult due to the middle segments of the screws remaining in the calcaneus, anchored into position.Due to difficulties, the surgeon reverted to his 3rd choice method of removal, which was to cut a medial window in the tibial (bone) and use a hammer to slowly push the nail out through the calcaneus.This was successful and the nail and middle segments of the calcaneal screws were removed.

Manufacturer Narrative

Integra has completed their internal investigation on 8jan2016.The additional investigation activities included: methods: review of device history records.Review of complaint history.Results: a review of the device history cannot be performed as no lot number was provided to newdeal.A review of the complaint system was performed.This is the third incident reported to newdeal about breakage of a panta® nail fully threaded screw diameter 5mm for the past two years (5 screws are involved).During the same time period, about 5811 panta® nail fully threaded screws diameter 5mm were sold.(b)(4).Conclusion: given the description of the event, the observations made during the investigation and the lack of important information such as manufacturing lot or product return, the root cause of the incident cannot be determined even if an improper initial positioning of the nail can be suspected due to revision surgery observations done by surgeon.

• Brand Name: PANTA NAIL SCREW - UNSPECIFIED
• Type of Device: N/A
• 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: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5267976
• MDR Text Key: 32747229
• Report Number: 9615741-2015-00063
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K091788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-PANTA NAIL SCREW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/29/2016
• 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): Required Intervention