MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC POWER MODULE FOR TRAUMA RECON SYSTEM; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 05.001.202

Device Problem Unintended System Motion (1430)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device failed pre-test for check for unintended motion with handpiece, therefore, the reported condition that the device was not working was confirmed.The assignable root cause of this condition was determined to be traced to component failure.If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).

Event Description

It was reported from (b)(6) that during service and evaluation, it was determined that the power module device did not function.It was further determined that the device failed pretest for function- test, saw- test, charging and checking of power module in charger, check for unintended motion with handpiece, check in ¿off/lock¿ mode with handpiece, and information button and self-test.It was noted in the service order that the device was not working.This event did not occur during surgery.There was no patient involvement.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

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 h10: subsequent investigation was performed and the investigation has been updated.It was inadvertently reported in the initial report that the device failed pretest for check for unintended motion with handpiece, therefore the failure has been removed.The reported event (device not working) does not meet the criteria of a reportable complaint as it is unlikely to cause or contribute to serious injury.Therefore, the initial medwatch report was submitted in error.No further investigation will be performed at this time.

• Brand Name: POWER MODULE FOR TRAUMA RECON SYSTEM
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9503545
• MDR Text Key: 189617221
• Report Number: 8030965-2019-71274
• Device Sequence Number: 1
• Product Code: MOQ
• UDI-Device Identifier: 07611819977822
• UDI-Public: 7611819977822
• 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: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1