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

Catalog Number 03.404.035

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2023

Event Type  malfunction  

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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.H6: photo investigation: the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that the shaft of 03.404.035, drive shaft f/ria 2 l520 is broken.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 03.404.035, drive shaft f/ria 2 l520 would contribute to the complained device issue.Based on the investigation findings, potential cause can be traced to component failure and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.The device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.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 depuy synthes reports an event in colombia as follows: it was reported that during a procedure on (b)(6) 2023 a drive shaft split and the synream reaming rod folded.This report is for one (1) drive shaft for ria 2 520mm this is report 1 of 1 for complaint (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: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18251792
• MDR Text Key: 329571496
• Report Number: 8030965-2023-15228
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07612334143037
• UDI-Public: (01)07612334143037
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.404.035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SYNREAM REAMING ROD ø2.5 LONG L1150