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

Catalog Number 532.010

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.A visual and functional assessment was performed which found that the device had low power, ran very slow and was sluggish.It was further observed that the device was not functioning with the epd-console.During service/repair, it was determined that there was damage insulation on the electronic control unit (ecu)-wire, the magnet from the control lever came out and the bearings and seals were worn out.The assignable root cause was determined to be due to normal wear out from use.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during pre-surgery, it was discovered that the small battery drive device was not holding the charge well, had low power and was running sluggishly.During in-house engineering evaluation, it was observed that the magnet from the control lever came out.It was not reported if there were any delays in a surgical procedure or if a spare device was available.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.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.

• Brand Name: SMALL BATTERY DRIVE
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7369231
• MDR Text Key: 103417063
• Report Number: 8030965-2018-52387
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 7611819110779
• UDI-Public: (01)7611819110779(11)011112
• 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: 02/06/2018

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: 532.010
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 03/26/2018
• Date Device Manufactured: 11/12/2001
• 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