MAUDE Adverse Event Report: SYNTHES OBERDORF BATT F/NOS. 532.101+532.110; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 532.103

Device Problems Overheating of Device (1437); Defective Component (2292); Charging Problem (2892)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The contact¿s phone number was not provided.This 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.It was further determined that there were no signs of damage by dropping/ liquid or manufacturing error.It was determined that the wrong charger device (530.400) was used.It was further determined that there was a depth discharge because the battery remained on the battery casing/ handpiece device.It was determined that the battery device malfunctioned and was damaged.The assignable root cause was determined to be due to improper maintenance, which is user error, misuse, and / or abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported by (b)(6) that the battery device had trouble loading (issues by charging).It was further determined that the device was not functioning and was defective.During the pre-repair diagnostics assessment, it was determined that the contacts were heating and there was discoloring on the black signs of the battery housing.It was further determined that the battery had no voltage (< 1.0v) and the cells were defective.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: BATT F/NOS. 532.101+532.110
• 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: 6031148
• MDR Text Key: 57802359
• Report Number: 8030965-2016-15182
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.103
• Device Lot Number: 150428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2016
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2015
• 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