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

Catalog Number 532.010

Device Problems Device Stops Intermittently (1599); Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the forward and reverse triggers were functioning intermittently on the small battery drive device.It was reported that the event occurred during use on a patient.It was reported that the device was being used for treatment.It was not reported if there were any delays in the surgical procedure or if a spare device was available.There was patient involvement reported.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.It was reported that no adverse event occurred.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.

Manufacturer Narrative

The actual device was returned for evaluation.The small battery drive device was evaluated and the reported condition that the device forward and reverse triggers were functioning intermittently was confirmed.An assessment was performed and it was determined that the unit would not oscillate when both triggers were pressed, and the upper trigger was binding.It was further determined that the coupling head was worn, the electric control unit was shorted internally, and the stop ring of the lower trigger was worn.The assignable root cause was determined to be component wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: SMALL BATTERY DRIVE (COLIBRI)
• 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: 6743558
• MDR Text Key: 81129512
• Report Number: 8030965-2017-13853
• 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: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.010
• Device Lot Number: 004326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2010
• 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