MAUDE Adverse Event Report: SYNTHES GMBH UNIV-BATTERY CHARGER F/SYNTHES BATT 2 CH

Catalog Number 530.600

Device Problem Device Slipped (1584)

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

Event Type  malfunction  

Event Description

The customer returned the device reporting the charger tray in casing was loose.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Synthes is submitting this report as a result of remediation activities related to synthes ous service and repair files legacy review/remediation protocol-complaint handling and mdr reporting.Device listed in this report is used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.During pre-repair assessment performed by technician, functional testing was performed and revealed the housing was broken.This was contributed to normal wear of the device.Maintenance was performed.Device was repaired and returned to the customer on (b)(4) 2012.Placeholder.

• Brand Name: UNIV-BATTERY CHARGER F/SYNTHES BATT 2 CH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer (Section G): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 4084119
• MDR Text Key: 4850285
• Report Number: 8030965-2014-01135
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Occupational Therapist
• Type of Report: Initial
• Report Date: 10/16/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.600
• Device Lot Number: 22330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1