MAUDE Adverse Event Report: NEWDEAL SAS BOLD 2,5 CANNULATED DRILL - AO"2 IN 1"L.12MM; FOREFOOT SET INSTRUMENTS

Catalog Number 229027ND

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Integra has completed their internal investigation on 14nov2016.The investigation activities included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: dhr for lot f8bb reviewed and no anomalies associated with the complaint were observed.A review of the complaint system was performed.This is the first reported to newdeal about a breakage of bold® 2.5mm cannulated drills for the past two years.During the same time period, (b)(4) bold® 2.5mm cannulated drills were sold.The complaint rate for this kind of incident during the stated time period is (b)(4).It is the first recorded for lot f8bb.Product returned and evaluation verified complaint as not valid.The device is compliant and no failure observed.The k-wire is broken in the cannulated drill.Incident unrelated to device.Conclusion: the incident is not confirmed.

Event Description

This event involved 1 procedure, 1 patient, 2 devices.This is report 2 of 2.Mfr report numbers: 9615741-2016-00062; 9615741-2016-00063.It was reported the device broke during a procedure.At the end of the surgery the k wire broke in the drill and is blocked.No impact for the patient.It happens sometimes but the care team usually manages to take off the k wire in the drill.No patient injury is alleged.The event did not lead to an increase of surgery time.

• Brand Name: BOLD 2,5 CANNULATED DRILL - AO"2 IN 1"L.12MM
• Type of Device: FOREFOOT SET INSTRUMENTS
• 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: 6124609
• MDR Text Key: 60878402
• Report Number: 9615741-2016-00063
• 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: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/02/2016

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 229027ND
• Device Lot Number: F8BB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 115008SND / K WIRE 0.8MM