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 Intermittent Energy Output (4025)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

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.(b)(4).

Event Description

It was reported from (b)(6) that the small battery drive device was functioning intermittently.It was not reported if the event occurred during a surgical procedure.It was not reported if there was a delay to a planned procedure.It was not reported if there was a spare device available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported, however, it was reported that the event occurred in 2019.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

H10: depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Correction: d10: the date returned to manufacturer was documented as september 27, 2019 on the initial report.This date has been updated to october 2, 2019.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device was working intermittently with two batteries and the adapter device.It was further determined that the device failed pretest for check for off/oscillation/on switch mode function, check for compatibility between colibri/small battery drive (sbd) and colibri ii/sbd ii, check for the function with electric pen drive (epd)-console, check trigger and electronic control unit (ecu) function, check switching function, and check oscillation angle.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to improper cleaning and maintenance, which is user error/misuse/abuse.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
• MDR Report Key: 9158503
• MDR Text Key: 165962317
• Report Number: 8030965-2019-69048
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819110779
• UDI-Public: 7611819110779
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1