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

Catalog Number 05.001.202

Device Problems Device Inoperable (1663); Vibration (1674); Failure of Device to Self-Test (2937)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (b)(6).The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was not determined.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported by (b)(6) that during service and evaluation, it was observed that the power module device led lamps were red and lit with service bit 5 set and there was vibration observed.It was further observed that the device failed pre-test for information button, self test, charging and checking of power module, function test and saw test.It was noted in the service order that the device did not work.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5514135
• MDR Text Key: 41051202
• Report Number: 8030965-2016-11884
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• 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: 03/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2015
• 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