MAUDE Adverse Event Report: SYNTHES OBERDORF POWER MODULE F/TRS; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 05.001.202

Device Problems Device Operates Differently Than Expected (2913); Temperature Problem (3022)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported from (b)(6) that preoperatively, it was observed that the power module device was running hot during charging.It was further observed that the device would lose energy faster than usual during use.It was reported that there was no delay in a scheduled surgical procedure as unspecified spare device were available for use.The reporter stated that there were no issues with the other power modules.There was no patient involvement reported.There were no patient or user injuries reported.It was reported there was no medical intervention or prolonged hospitalization.The exact date of the event was not provided.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition of the power module is running hot during charging and was losing energy faster than usual during use confirmed.An assessment was performed on the device which determined the power module is functional although the power (177 w) was below specification (180 w).It was determined that the duty cycles may not have been followed accordingly.Additionally, it was found that the lever was defective.It was determined that handling /maintenance procedures were not followed as per the directions for use (dfu).The assignable root cause was determined to be due to improper handling.This is further defined as misuse, abuse, and possible user error.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: POWER MODULE F/TRS
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5552299
• MDR Text Key: 42617962
• Report Number: 8030965-2016-12261
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1