MAUDE Adverse Event Report: SYNTHES GMBH UNIUM¿ MODULAR HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 05.001.601

Device Problems Mechanical Jam (2983); Output below Specifications (3004); Physical Resistance/Sticking (4012)

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

Event Date 01/08/2024

Event Type  malfunction  

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.Udi:(b)(4).The actual device was returned for evaluation.During evaluation it was determined that the initial reported condition of the device not working in reverse mode; and sometimes was running fine but sometimes was running slow with less torque and rpm was not confirmed.Therefore, the assignable root cause was not determined.However, the malfunction found during service and evaluation has been confirmed.The assignable root cause was determined to be due to component wear.

Event Description

It was reported from india that during service and evaluation, it was determined that the handpiece device had a sticky trigger.It was further determined that the device failed pretest check for sticky triggers.It was noted in the service order that the device was not working in reverse mode; and sometimes was running fine but sometimes was running slow with less torque and rpm.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.

• Brand Name: UNIUM¿ MODULAR HANDPIECE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 18652823
• MDR Text Key: 334742403
• Report Number: 8030965-2024-02047
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1