MAUDE Adverse Event Report: SYNTHES WALDENBURG SMALL BATTERY DRIVE; INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH

Catalog Number 532.001

Device Problem Failure to Run on Battery (1466)

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

Event Type  malfunction  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the device does not always start, and the speed of the device is not always the same.This is report 1 of 1 for complaint (b)(6).

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device is an instrument and is not implanted/ explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.

Manufacturer Narrative

Additional narrative: subject device has been received and is currently in the evaluation process.A service history review was conducted.The report indicates that the device has not been serviced during the past 6 months.There is no information relevant to the current complaint issue.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: the investigation is based on the service & repair record received.The device failure reported by the customer could be confirmed.The service history review shows no previous service conditions relevant to the current complaint issue.The service technician noted the following action taken: repair.The device has been serviced and functional testing has been performed in accordance with the service manual 532.001.During the pre-repair diagnostic assessment the service technician identified the following failure: control unit not functioning defective.The root cause of the event was determined to be normal wear.The device was repaired and returned to the customer if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SMALL BATTERY DRIVE
• Type of Device: INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): SYNTHES WALDENBURG; hauptstrasse 24; waldenburg CH44 37; SZ CH4437
• Manufacturer (Section G): SYNTHES WALDENBURG; hauptstrasse 24; waldenburg CH44 37; SZ CH4437
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3677272
• MDR Text Key: 4256180
• Report Number: 3009450871-2014-10015
• Device Sequence Number: 1
• Product Code: HWE
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1