MAUDE Adverse Event Report: SYNTHES GMBH 12MM/125 DEG TI CANN TFNA 340MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.037.224S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from switzerland reports an event as follows: it was reported that on (b)(6) 2024, a nail breakage occurred.The original procedure was performed on (b)(6) 2023.No fragments were retained within the patient.A revision procedure to address the issue was planned.No further information is available.This report is for a 12mm/125 deg ti cann tfna 340mm/right ¿ sterile.This is report 1 of 1 for (b)(4).
Additional 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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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.
Additional 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: d4: lot and expiration date d9.H3, h4, h6: part # 04.037.224s, synthes lot # h843290, supplier lot # h843290, release to warehouse date: 18 mar 2019, manufactured by: synthes monument.No ncrs 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.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that had broken from the proximal tip.The allegation of broken can be confirmed.The broken fragment was returned for evaluation.While no root cause can be established with the available information, factors such as the age of the patient, underlying disease, bone density, or a possible early weight-bearing, could have led to failure of the implant.A dimensional inspection for the device was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the tfna fem nail ø12 r 125° l340 timo15 would contribute to the complained device issue.Based on the investigation findings, 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 reported 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: 12MM/125 DEG TI CANN TFNA 340MM/RIGHT - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 18856062
• Report Number: 8030965-2024-03333
• Device Sequence Number: 3314427
• Product Code: HSB
• UDI-Device Identifier: 10886982097101
• UDI-Public: (01)10886982097101
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 04.037.224S
• Device Lot Number: H843290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown