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

Catalog Number 532.110

Device Problem Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The reporter¿s phone number was not provided.The actual device was returned for evaluation.The device was evaluated and the reported condition was confirmed.A visual and functional assessment was performed which found that the device was not working (failed off/oscillation/on switch mode function).During service/repair, it was determined that the motor was damaged and it worked intermittently.It was observed that the insulation was damaged on the electronic control unit (ecu) wire.It was further determined that the bearings and seals were worn.The assignable root cause was determined to be due to normal wear.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported that during testing, it was discovered that the small battery drive device would not function.During in-house engineering evaluation, it was observed that the motor was damaged and it worked intermittently.The event was not related to surgery.There was no patient involvement.There were no injuries or medical intervention associated with this event.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 II
• 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): SYNTHES PRODUKTIONS GMBH; hauptstrasse 24; waldenburg 4437 ; SZ 4437
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7625932
• MDR Text Key: 112368494
• Report Number: 8030965-2018-54479
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 7611819408357
• UDI-Public: (01)7611819408357(11)150416
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.110
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Date Manufacturer Received: 05/29/2018
• Date Device Manufactured: 04/16/2015
• 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