MAUDE Adverse Event Report: NEWDEAL SAS QWIX FIXATION SCREW 4.3MM DIAMETER ¿ UNSPECIFIED LENGTH

Catalog Number XXX-QWIX 4.3 SCREW

Device Problems Break (1069); Material Fragmentation (1261); Difficult to Remove (1528); Material Integrity Problem (2978)

Patient Problems Fever (1858); Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Device Embedded In Tissue or Plaque (3165)

Event Date 03/11/2015

Event Type  Injury  

Event Description

It was reported a, "product defect of the qwix screw had caused the personal damage and moral damage of the patient." "the left tibial plateau was fractured due to a car accident happened on (b)(6) 2014.With a qwix screw manufactured by your company, my client received an open reduction and internal fixation surgery of the left tibial plateau on (b)(6) 2014.During the postoperative removal of internal fixator of the left tibial plateau under general anesthesia carried out on (b)(6) 2015, the qwix screw was sheared off at the end of it and there was no sign that it could be removed away from my client without any harm.At the present, the fraction of the broken qwix screw was still stayed inside the left tibial plateau of my client and it significantly affected the function of his left leg while client is suffering a frequent local pain and discomfort, pyrexia, made him had a difficulty in walking.In my submission (opinion), it was the product defect of qwix screw made it shear off during surgery, and it had seriously influenced the function of the left leg of my client.Customer is looking for compensation for the personal damage and moral damage of my client.".

Manufacturer Narrative

Integra completed its internal investigation 24jun2016.The investigation included: method: review of device history records.Review of complaint management database for similar complaints.Results: the device was not returned and the lot number is not provided by customer.No mean to review the device history records of this lot for the moment.A review of the complaint system was performed.This is the first incident reported to newdeal for postoperative breakage of qwix screws (for the past two years).During the same time period, about (b)(4) qwix screws diameter 4.3 mm have been sold.The complaint rate for this kind of incident during the stated time period is (b)(4) percent.We do not have any information concerning the number of lot, so we cannot evaluate the lot failure rate.Conclusion: the device was not returned and the number of lot is unknown, so the root cause cannot be determined.

• Brand Name: QWIX FIXATION SCREW 4.3MM DIAMETER ¿ UNSPECIFIED LENGTH
• Type of Device: QWIX
• 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: 5755400
• MDR Text Key: 48339870
• Report Number: 9615741-2016-00043
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: K050346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 06/07/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-QWIX 4.3 SCREW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2016
• Initial Date FDA Received: 06/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2016
• 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): Disability