MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC INTERACTIVE PRECISION IO SCAN ADAPTER

Catalog Number 6534-09PT

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 10/11/2018

Event Type  malfunction  

Manufacturer Narrative

This complaint was initially evaluated as not-reportable for mdr submission as there was no patient involvement and device evaluation results indicate excessive force used.This complaint is being reported due to a recall notification submitted on 01/23/2019 under rcr report number: 3001617766-01/10/2019-001-r.

Event Description

Per complaint (b)(4), during unpacking, the scan adapter body was in two parts.The plastic came off the base.

• Brand Name: INTERACTIVE PRECISION IO SCAN ADAPTER
• Type of Device: SCAN ADAPTER
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: adrienne stott ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 8363638
• MDR Text Key: 137855204
• Report Number: 3001617766-2019-00066
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307123477
• UDI-Public: 10841307123477
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 872.398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/22/2019

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 Expiration Date: 11/19/2022
• Device Catalogue Number: 6534-09PT
• Device Lot Number: 104963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: SEE H10
• Patient Sequence Number: 1