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

Catalog Number 05.001.202

Device Problem Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

Udi: serial number unknown; (b)(4).The manufacturing location was unknown.The serial number was unknown; therefore, the device manufacture date is unknown.Concomitant medical devices: lid devices, battery handpiece/modular device, power module device, (b)(6) 2019.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.

Event Description

This is report 2 of 3 for the same event: it was reported from (b)(4) that during an open reduction and internal fixation (orif) surgery for a trochanteric fracture of the femur, it was discovered that the power module devices, battery handpiece/modular device and lid devices did not work at all.According to the reporter, the devices were confirmed to have been working properly before sterilization.However, the devices stopped working during use.It was reported that the surgeon changed the power module and the lids; however, the issue did not improve.There were no delays to the surgical procedure as spare devices were used to complete the surgery.There was patient involvement reported.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

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.Udi: (b)(4).Serial number: the serial number was unknown in the initial report.The serial number has been updated as (b)(4).The actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report 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.G1-2: the manufacturer location was unknown in the initial report.The location has been updated to oberdorf.The contact office name/address has been updated accordingly to reflect the corrected manufacturing facility.H4: device manufacture date: the device manufacture date was unknown in the initial report.The device manufacture date has been updated as 12/1/2017.Device history record review: a device history review was performed and no non-conformances were detected related to the reported condition.Device evaluation: the actual device was returned for evaluation.During repair, it was determined that the motor was worn out due to normal wear.It was further determined that the cause of the motor loose fixation and the electronic control unit (ecu) damage were due the improper handling.It was determined that the motor had a loose fixation, the device would not run, and the electrical control unit was damaged.It was determined that the root cause of the issues was traced to the user.It was further determined that the worn motor was caused by component failure.It was determined that the led warning light had an indicator error and the device would not charge.It was determined that the root cause could not be not established regarding the issue.It was further determined that the device failed pretest for check position of motor shaft, check motor shaft abrasion and free moving, information button and self-test, charging and checking of power module in charger , function test and saw test.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to component failure, which was traced to the user.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• 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: 9156310
• MDR Text Key: 196198755
• Report Number: 8030965-2019-68725
• Device Sequence Number: 1
• Product Code: MOQ
• UDI-Device Identifier: 07611819977822
• UDI-Public: 07611819977822
• 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,Followup
• Report Date: 09/12/2019

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: 05.001.202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Date Manufacturer Received: 10/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1