MAUDE Adverse Event Report: SYNTHES GMBH COLIBRI

Catalog Number 532.001

Device Problems Overheating of Device (1437); Noise, Audible (3273)

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

Event Type  malfunction  

Event Description

Customer reported the motor got hot and loud.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.During pre-repair assessment performed by a technician, functional testing was performed and revealed the motor seized and was jammed.Parts were replaced, the device was repaired and returned to the customer on (b)(4) 2013.Placeholder.

• Brand Name: COLIBRI
• 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: 4145935
• MDR Text Key: 22262356
• Report Number: 8030965-2014-00839
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.001
• Device Lot Number: 2775_R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1