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

Catalog Number 05.001.202

Device Problems Premature Discharge of Battery (1057); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2023

Event Type  malfunction  

Event Description

It was reported that during pre-surgery testing it was observed that the power module device would not hold a charge.During in-house engineering evaluation it was determined that the device was leaking liquid.This event did not occur during surgery.There was no patient involvement.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 will be submitted accordingly.

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.H10 additional narrative: the actual device was returned for evaluation.The power module device was evaluated and the reported condition that the device would not hold a charge was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device was leaking liquid, the housing was cracked/damaged, and led warning light indicator error.It was further determined that the device failed pretest for general condition and lever function, information button and self-test, and check liquid indicator.The assignable root cause of these conditions was determined to be traced to the user, which is user error.Udi ¿ (b)(4).

• Brand Name: POWER MODULE FOR TRAUMA RECON SYSTEM
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 17435847
• MDR Text Key: 320154118
• Report Number: 8030965-2023-09634
• Device Sequence Number: 1
• Product Code: MOQ
• UDI-Device Identifier: 07611819977822
• UDI-Public: 07611819977822
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• 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: 07/14/2023
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2016
• 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