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

Catalog Number 532.101

Device Problem Intermittent Energy Output (4025)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2019

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The actual device was returned for evaluation.During evaluation of the device, it was determined that the device would not run - motor damaged.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to premature wear.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Event Description

It was reported from (b)(6) that the small battery drive device was working on and off when the trigger was pressed and had a significant lack of power.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.All available has been disclosed.If additional information were to become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: COLIBRI II
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 9128346
• MDR Text Key: 160480143
• Report Number: 8030965-2019-68662
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Date Manufacturer Received: 09/13/2019
• Date Device Manufactured: 03/26/2019
• 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