MAUDE Adverse Event Report: SYNTHES GMBH COLIBRI

Catalog Number 532.001

Device Problems Device Operates Differently Than Expected (2913); Temperature Problem (3022)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Customer reported the drill was running at 400 rpm and the coupling heated up when the attachment was attached.According to the customer, by tilting the device it sounded like it went faster.This is report 1 of 1 for #(b)(4).

Manufacturer Narrative

Synthes is submitting this report as a result of remediation activities related to synthes 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 technician, investigation revealed the control unit was defective and not functioning properly.The device was repaired and returned to customer on (b)(4) 2013.The complaint is indeterminate.The 510k#: device is not distributed in the united states, but is similar to device marketed in the usa.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: 4033852
• MDR Text Key: 4726996
• Report Number: 8030965-2014-00891
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 12255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2013
• Initial Date FDA Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1