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 Excessive Heating (4030)

Patient Problem Not Applicable (3189)

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Concomitant medical products and therapy dates: small battery drive casing device, (b)(6) 2020.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be submitted accordingly.(b)(4).

Event Description

It was reported that during pre-surgery, it was discovered that the small battery drive device overheated while being used together with the battery drive casing device.It was further reported that the device was spinning slowly.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There was no human patient involvement as the device was a veterinary device.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 report will be submitted accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that there was an unknown substance on the motor and motor plate.It was further observed that the device had a corrosive substance and was overheating.It was further determined that the device would not run.It was further determined that the device failed pretest for check oscillation/forward/reverse mode function assessment and check power with test bench assessment ¿ device not running/functioning.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to maintenance, which is improper maintenance.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
• MDR Report Key: 10258034
• MDR Text Key: 198345294
• Report Number: 8030965-2020-04666
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819408357
• UDI-Public: 07611819408357
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 06/29/2020

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: 532.110
• Device Lot Number: 1399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1