MAUDE Adverse Event Report: SYNTHES GMBH DRIVE SHAFT FOR RIA 2 520MM; REAMER

Catalog Number 03.404.035

Device Problems Break (1069); Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is synthes sales representative.The complaint condition was not confirmed for the drive shaft f/ria 2 l520 (p/n: 03.404.035, lot #: h860686).During investigation it was found the device broken from the aspiration port and the tube assembly is deformed.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to the usage of a greater torque and rpm than is indicated in the technique guide, as it states ¿select a power drive unit that will deliver 3.5 nm to 6.0 nm of torque and 700 rpm to 900 rpm.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part # 03.404.035, synthes lot # h860686, supplier lot # h860686, release to warehouse date: 22 oct 2019; 05 nov 2019, supplier: mark two engineering inc., no ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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.

Event Description

Device report from synthes reports an event in france as follows: it was reported that the device was received as broken and deformed.It is unknown when the issue occurred.No patient involvement reported.This report is for one (1) drive shaft for ria 2 520mm.This is report 1 of 1 for (b)(4).

• Brand Name: DRIVE SHAFT FOR RIA 2 520MM
• 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: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13227003
• MDR Text Key: 289442215
• Report Number: 8030965-2022-00235
• 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: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 01/11/2022
• 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: H860686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2019
• 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