MAUDE Adverse Event Report: NEWDEAL SAS QWIX FIXATION SCREW - 3MM DIAM. X 14MM LG - STER

Catalog Number 111314SND

Device Problem Device Expiration Issue (1216)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2018

Event Type  malfunction  

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

It was reported that an expired implant was used in a patient.No consequences for the patient.

Manufacturer Narrative

Conclusion - further to the investigation, it appears that the customer has been informed of the expiration date of the item before the surgery, according to the consignment contract signed between integra and the customer.In addition, this is the responsibility of the hospital to check the expiry date of the product they have in consignment before implanting it into the patient.Dhr conclusions - no design or process change could be linked to this incident.Specifications that could be linked to this incident are checked prior to release.

• Brand Name: QWIX FIXATION SCREW - 3MM DIAM. X 14MM LG - STER
• Type of Device: QWIX
• Manufacturer (Section D): NEWDEAL SAS; 97 allee alexandre borodine; 97 allee alexandre borodine; saint priest 69800 ; FR 69800
• MDR Report Key: 7299101
• MDR Text Key: 101468491
• Report Number: 9615741-2018-00054
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: K953406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 111314SND
• Device Lot Number: F4YX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1