MAUDE Adverse Event Report: SYNTHES GMBH POWER MODULE F/TRS

Catalog Number 05.001.202

Device Problem Loss of Power (1475)

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

Event Type  malfunction  

Manufacturer Narrative

Synthes is submitting this report as a result of remediation activities related to (b)(4) and repair files legacy review/remediation protocol-complaint handling and mdr reporting.Blank fields on this form indicate the information is unknown, unavailable or unchanged.Device listed in this report is used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.During pre-repair assessment performed by technician, functional testing was performed and no failure was identified.The device was returned to the customer on 10/15/2012.Placeholder.

Event Description

It was reported that the device stopped during surgery, it could not reload.This is report 1 of 1 for complaint #(b)(4).

• Brand Name: POWER MODULE F/TRS
• 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: 4143450
• MDR Text Key: 19372029
• Report Number: 8030965-2014-01525
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.202
• Device Lot Number: 3550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2012
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/08/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1