MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC CHUCK WITH KEY F/BPL; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.730

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.The actual device was returned for evaluation.The chuck with key device was evaluated and the reported condition that the device was loses all torque power when pressure was applied to bone was confirmed.An assessment was performed and it was observed that the drill chuck would not spin when pressure was added, and the device had wobbling / inconsistent rotation movement.It was further determined that the device failed pretest for free movement and untrue running.During repair it was observed that the transmission shaft was broken and there was an unknown debris on the bearings.The assignable root cause was determined to be due to improper handling, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported that the chuck with key device lost all torque power when pressure was applied to the bone while in use with drill/reamer bit device.During in-house engineering evaluation, it was observed that the transmission shaft was broken on the device and there were unknown debris on the ball bearings.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.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of the 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: CHUCK WITH KEY F/BPL
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• 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: michael cote ; 1302 wrights lane east; west chester, PA ; SZ ; 6107195000
• MDR Report Key: 7629648
• MDR Text Key: 112368735
• Report Number: 8030965-2018-54516
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 7611819138667
• UDI-Public: (01)7611819138667(11)170615
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2018

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: 530.730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 06/22/2018
• Date Device Manufactured: 06/15/2017
• 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