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).

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.H11 additional narrative: h3, h6: the product was not returned to depuy synthes, however two (2) photos were provided for review.The photos were reviewed and the first photo showed the area of the shaft that had the etching with the part and lot number.The second photo showed the tip of the shaft that was inside the trial tip up to the area where the tip had been welded to the shaft.The trial tip was not attached to the end of the shaft in the photo.Approximately half of the circumference is visible and the weld area appears to be continuous with no defects observed.One side of the hole through the tip of the shaft is visible and the connection pin for the shaft and trial tip is still in the hole and appears to be sheared off flush with the shaft diameter.No x-rays were provided for investigation so the reported condition of embedded device could not be confirmed.The overall complaint was confirmed as the photos show that the trial tip was no longer attached to the shaft.The area of the weld that is visible is continuous with no issues identified and the connecting pin was present but had been sheared off when the trial tip broke.Based on the investigation findings, a potential cause cannot be established, 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.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: 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,Followup

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: 03.809.629
• Device Lot Number: T170514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• 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