MAUDE Adverse Event Report: NEWDEAL SAS QWIX FIXATION SCREW 4.3MM DIAMETER X 34MM LENGTH; QUIX

Catalog Number 111434SND

Device Problem 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.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

2 of 5 reports (same event, same patient, different products) other mfg report numbers: 9615741-2020-00013, 9615741-2020-00015, 9615741-2020-00016, 9615741-2020-00017.A facility reported that on (b)(6) 2019 the patient had an arthrodesis procedure and after 9 months it became into pseudoarthrosis.The surgeon thinks that he might given a longer cast period to immobilize the foot.Revision was performed and was replaced with another plate system.It was reported the x-rays showed that the implant did not failed.Additional information has been requested.

Event Description

N/a.

Manufacturer Narrative

Device identifier: (b)(4).Results of the documentary investigation does not reveal any issue about the design, the manufacturing or the inspection of concerned product lots.Investigation for cause cannot be performed as the product is unavailable.Regarding clinical review, the patient conditions (smoker) and / or the post-surgical treatment (that was not fully compliant with non-weight bearing instruction) can be found as root cause of the incident.

• Brand Name: QWIX FIXATION SCREW 4.3MM DIAMETER X 34MM LENGTH
• Type of Device: QUIX
• Manufacturer (Section D): NEWDEAL SAS; 97 allee alexandre borodine; 97 allee alexandre borodine; saint priest 69800 ; FR 69800
• MDR Report Key: 10877457
• MDR Text Key: 217458106
• Report Number: 9615741-2020-00014
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K053046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 111434SND
• Device Lot Number: FB47
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1