MAUDE Adverse Event Report: DEPUY SYNTHES USA BATTERY RECIPROCATOR

Catalog Number 530.615

Device Problems Sticking (1597); Device Inoperable (1663); Component Missing (2306); Temperature Problem (3022)

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

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.The additional evaluation indicates that the reporter did not allege or identify any deficiency; it was observed during functional testing that the device had high temperature, sticky trigger and missing component.Evidence suggests this is due to improper handling.A service history of the past six months has been reviewed.No service history review can be performed.The item has not previously been in for service.There is no information relevant to the current complained issue.The manufacture date of this item is 18-mar-2010.The source of the manufacture date is the release to warehouse date from docusphere.Device is an instrument and is not implanted/explanted.Placeholder.

Event Description

It was reported that the battery reciprocator had an unspecified malfunction.During evaluation, it was discovered that the device had a high temperature, a sticky trigger and a missing component.This is report 1 of 1 for complaint (b)(4).

• Brand Name: BATTERY RECIPROCATOR
• Manufacturer (Section D): DEPUY SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3899946
• MDR Text Key: 19451972
• Report Number: 2520274-2014-01030
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2013

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 Catalogue Number: 530.615
• Device Lot Number: 2988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2013
• Initial Date FDA Received: 06/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1