MAUDE Adverse Event Report: SYNTHES OBERDORF AO REDUCTION DRIVE UNIT; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 532.017

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device would not hold the coupling gage nor rotate.Therefore, the reported condition was confirmed.It was further noted that the internal components were corroded.The assignable root cause was determined to be wear on mechanical components from repeated sterilization and use over time.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 that during routine maintenance, it was observed that the small battery drive device would not hold the attachment devices.This event was reported to not have occurred during surgery.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event is not known.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: AO REDUCTION DRIVE UNIT
• 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: 5304271
• MDR Text Key: 34355235
• Report Number: 8030965-2015-12344
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.017
• Device Lot Number: MA1010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2015
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2004
• 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