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

Catalog Number 532.001

Device Problem Device Stops Intermittently (1599)

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 run, or when running does not stop running, regardless of actions taken to switch off the device.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

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

Device was used for treatment, not diagnosis.Additional narrative: the investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.A service history review of the device has been performed.The review indicates that the device has not been serviced during the past six months.There is no information relevant to the current complaint issue.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: the service history review indicates that the device has not been serviced during the past 6 months.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.After pre-repair diagnostic assessment, the device has not been serviced.The service technician noted the following action taken maintenance and inspection.During the pre-repair diagnostic assessment the service technician identified the following failure positioning defect, housing worn-out, bearing defect.The root cause of the event was determined to be normal wear.The device was repaired and returned to customer.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.

• 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: 3709463
• MDR Text Key: 4229190
• Report Number: 3009450871-2014-10041
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• 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: 03/13/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2002
• 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