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

Catalog Number 05.001.202

Device Problem Loss of Power (1475)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/19/2013

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: the power module was suddenly powered off, the signal for malfunction was shown, the red light was on, even if it was not able to charge the malfunction light was still on.The battery was used since (b)(6) 2013.It was reported: the patient was bleeding a lot, the surgery was delayed and no another instrument was available for use; the additional medical treatment was required.This is 1 of 1 report for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).The manufacturing documents were reviewed and no complaint related issues were found.The device was returned and the investigation is ongoing.Device is an instrument not implanted/explanted.Placeholder.

Manufacturer Narrative

According to the product development evaluation and additional evaluation, the device was received with no visible damages.The investigation noted that the battery came from the customer discharged to low level and is irreparably.The power module was also checked and the led lights red, which means that the power module is faulty.The manufacturing documents where reviewed and no discrepancies to the specifications where found.No product fault was detected.It was determined that inappropriate handling led to the malfunction of this device.

Manufacturer Narrative

Initial mdr, mfr# 8030965-2014-00267 was filed in error.Upon further review this is a non-reportable event.

• Brand Name: POWER MODULE F/TRS
• Manufacturer (Section D): SYNTHES GMBH; eiamattstrasse 3; ch4436; oberdorf ; SZ
• Manufacturer Contact: sherry laing ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3618255
• MDR Text Key: 18299852
• Report Number: 8030965-2014-00267
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2014
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.202
• Device Lot Number: SER. NO 9474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 45