MAUDE Adverse Event Report: SYNTHES OBERDORF SMALL BATTERY DRIVE II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 532.110

Device Problems Battery Problem (2885); Mechanics Altered (2984)

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

Event Date 07/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.An assessment was performed on the device which found that the electronic control unit (ecu) was not functional and the electric motor had unusual vibration and was emitting a grinding noise.It was determined that the assignable root cause of this condition was due to component wear from normal use over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported that during pre-surgery testing, it was observed that the small battery drive device was not running.During in-house engineering evaluation it was found that the electronic control unit (ecu) was not functional and the electric motor had unusual vibration and was emitting a grinding noise.It was reported that there was no in a scheduled surgical procedure as an identical spare device was available for use.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 reported, however, it was noted that the event occurred in (b)(6) 2016.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: SMALL BATTERY DRIVE II
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5956787
• MDR Text Key: 55267559
• Report Number: 8030965-2016-14888
• Device Sequence Number: 1
• Product Code: HWE
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.110
• Device Lot Number: 1475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2016
• Date Manufacturer Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2014
• 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