MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS COLIBRI II. SMALL BATTERY DRIVE DEVICE II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 532.101

Device Problem Device Stops Intermittently (1599)

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

Event Date 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the small battery drive device did not work all the time.It was reported that the event occurred during use on a patient.It was not reported if there were any delays in the surgical procedure.It was reported that the surgery was completed using the same device.There was patient involvement reported.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The actual device was returned for evaluation.During repair, it was determined that the reported condition was confirmed.It was determined that the coupling tool side was jammed and was moving heavy.It was further determined that the nose seals, bearings and nose casing were worn.It was determined that the device operated intermittently.It was further determined that the device failed pretest for check the attachment coupling and check power with test bench, mln.67.5 to 110 w.The assignable root cause was determined to be due to improper handling.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: COLIBRI II. SMALL BATTERY DRIVE DEVICE II
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6598808
• MDR Text Key: 76244179
• Report Number: 8030965-2017-12651
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.101
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2013
• 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