MAUDE Adverse Event Report: SYNTHES GMBH ELECTRIC PEN DRIVE 60,000 RPM

Catalog Number 05.001.010

Device Problem Device Inoperable (1663)

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

Event Date 11/07/2013

Event Type  malfunction  

Event Description

Facility reported 05.001.010 (electric pen drive) does not work.No other information was provided.Update (b)(6) 2013 facility reported during ortho surgery 05.001.010 (electric pen drive) would not work.This is report 1 of 1 of complaint #(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Service history of the past six months from the awareness date was reviewed.No service history review can be performed.The item has not been in for service for the past six months.There is no information relevant to the current complained issue.The manufacturing documents were reviewed and no complaint related issues were found.The reporter's complaint that this device does not function could not be confirmed.The unit was tested and passed all manufacturing specifications.Placeholder.

• Brand Name: ELECTRIC PEN DRIVE 60,000 RPM
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer (Section G): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3984677
• MDR Text Key: 4818092
• Report Number: 8030965-2014-00600
• Device Sequence Number: 1
• Product Code: DZI
• 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: Invalid Data
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.010
• Device Lot Number: 4213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ELECTRIC PEN DRIVE 60,000 RPM