MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC HUDSON REDUCTION DRIVE UNIT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 532.018

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported that during an unspecified surgical procedure of the hip it was observed that the reduction drive device would not go in reverse.It was reported that there was no delay in the procedure due to the event was an unspecified spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Device was used for treatment, not diagnosis.The actual device was returned for evaluation.The device was evaluated and the reported condition was not confirmed.An assessment was performed and the device met all manufacture's specifications.Therefore, an assignable root cause was not determined.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: HUDSON REDUCTION DRIVE UNIT
• 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): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 33410 ; 6107195000
• MDR Report Key: 7212965
• MDR Text Key: 98190991
• Report Number: 8030965-2018-50567
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 10886982240521
• UDI-Public: (01)10886982240521(11)140625(10)MA1049
• 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,Followup
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.018
• Device Lot Number: MA1049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2014
• 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