MAUDE Adverse Event Report: NEWDEAL SAS SCREW + WASHER STERILE TITANIUM - DIA3.0 L18MM; N/A

Catalog Number 285118SND

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/03/2019

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that on (b)(6) 2019, the outer packaging of a screw (id 285118snd) has hair between the "bracking" paper and plastic packaging.The plastic packaging has not been opened.No patient contact / injury reported.The event lead to surgical delay, unknown for how long.

Manufacturer Narrative

Udi: (b)(4).Complaint sample was not returned to integra therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Manufacturer Narrative

Root cause: results of the documentary investigation does not reveal any issue about the design, and during the manufacturing or the inspection of products.No trend for this kind of incident is observed.Failure analysis confirmed the presence of the hair in the sealing of the external blister.

• Brand Name: SCREW + WASHER STERILE TITANIUM - DIA3.0 L18MM
• Type of Device: N/A
• Manufacturer (Section D): NEWDEAL SAS; 97 allee alexandre borodine; 97 allee alexandre borodine; saint priest 69800 ; FR 69800
• MDR Report Key: 8934498
• MDR Text Key: 166540014
• Report Number: 9615741-2019-00014
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K093914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2024
• Device Catalogue Number: 285118SND
• Device Lot Number: FSS2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1