MAUDE Adverse Event Report: SYNTHES GMBH ORACLE TRIAL SPACER 9MM HEIGHT/8 DEG ANGLE; TEMPLATE

Catalog Number 03.809.629

Device Problems Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 02/23/2024

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.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6 investigation summary: the product was not returned to depuy synthes, however photos were provided for review.Photos were provided for review, however the photos only show part and lot number and no other observation pertaining to the nature of the reported event could be identified.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.The overall complaint was unconfirmed as the photographs provided contained insufficient evidence of the reported event.Based on the investigation findings, 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.Device history: part number: 03.809.629.Lot number: t170514.Manufacturing site: tuttlingen.Release to warehouse date: 17-apr-2019.A review of the device history records was performed for the finished device lot number and a nc was identified for this lot.The issue within the nc is regarding water monitoring samples and is not related to the issue described within this complaint.The necessary actions to ensure the final product quality have been taken and documented in the appropriate quality system.The nc have no impact to the complaint condition.The final quality release criteria were met before this batch was released for distribution.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 china as follows: it was reported during surgery on (b)(6) 2023 the oracle trial (9mm) broke in the patient's body during surgery.Trial cannot be removed which caused the prosthesis to not be implanted.Patient was closed.The patient was currently hospitalized for observation.This report is for one oracle trial spacer 9mm height/8 deg angle for (b)(4).

• Brand Name: ORACLE TRIAL SPACER 9MM HEIGHT/8 DEG ANGLE
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18896433
• MDR Text Key: 337579379
• Report Number: 8030965-2024-03589
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10705034725468
• UDI-Public: (01)10705034725468
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• 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

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.809.629
• Device Lot Number: T170514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male