MAUDE Adverse Event Report: SYNTHES GMBH DRIVE SHAFT F/RIA 2 L520; REAMER

Catalog Number 03.404.035

Device Problems Break (1069); Device-Device Incompatibility (2919); Material Deformation (2976)

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

Event Date 02/29/2024

Event Type  malfunction  

Event Description

Device report from synthes reports an event in france as follows: it was reported on (b)(6) 2024, that-the intervention took place on (b)(6) at 11:30 am.The motor shaft ref.03,404,035 lot j008377 could not be used (unable to insert the motor shaft into the sterile tubing).The previous customer used this same guide as we found a blue joint (the rest of the sterile system that must have melted) and that the hard use had worn out the motor shaft.No patient consequence.This report is for one (1) drive shaft f/ria 2 l520.This is report 1 of 1 for complaint (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional product code: hrx complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.H4,h6 part # 03.404.035, synthes lot # j008377, supplier lot # j008377, release to warehouse date: 02 aug 2022 , supplier :(b)(4).A manufacturing record evaluation was performed and a non-related non-conformance device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DRIVE SHAFT F/RIA 2 L520
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18922388
• MDR Text Key: 337885491
• Report Number: 8030965-2024-03771
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07612334143037
• UDI-Public: (01)07612334143037
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: 0
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.404.035
• Device Lot Number: J008377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2022
• 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