MAUDE Adverse Event Report: SYNTHES OBERDORF COLIBRI; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 532.001

Device Problems Defective Component (2292); Device Operates Differently Than Expected (2913); Device-Device Incompatibility (2919); Naturally Worn (2988); Power Problem (3010); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Reporter's name and phone number were not provided.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was duplicated and confirmed.The assignable root cause was determined to be due to normal wear from use and servicing over time.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported from (b)(6) that the small battery drive device had an undetermined malfunction.During service and evaluation, it was observed that the small battery drive device control unit was not functioning, the motor was crunching and the coupling head was worn.It was further determined that the device failed the following pre-tests: check the off/osc/on switch mode function, check the oscillation angle, check switching function, check the triggers and electronic control unit (ecu) function, check compatibility between colibriisbd and colibri ii/sbd ii, check the function with electric pen drive (epd)-console and check power with test bench.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: COLIBRI
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6159352
• MDR Text Key: 62387300
• Report Number: 8030965-2016-15894
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• 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: 11/14/2016
• Date Manufacturer Received: 11/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1