MAUDE Adverse Event Report: SYNTHES GMBH 10/125 DEG TI CANN TFNA 400/RIGHT - SILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.037.030S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).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.H11 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2024, after drilling for the helical blade, during a tfna, our 10mm cannulated tapered drill bit came out with metal shavings.They took out the nail and inspected it and discovered the shavings had came from the nail.The nail was replaced with a brand new one of the same kind.The tray was not put up again for another surgery until hardware was inspected.A new nail was opened after cleaning the drill and surgery site.It still produced metal shaving, although fewer.The correct nail for the insertion arm was used and checked both times for alignment.The issue was that the nail's integrity may have been compromised.There was a surgical delay of 20 minutes.Procedure was completed successfully.There was no patient consequences.This report is for one (1) 10/125 deg ti cann tfna 400/right - sile this is report 1 of 2 for complaint (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.H11 additional narrative: h3, h6: the product was not returned to depuy synthes; however, photos were provided for review.Visual analysis of the video revealed that the mating blade cannot be assemble on the 10/125 deg ti cann tfna 400/right - sile, additionally, the coupling connection with the aim arm was observed with movement possibly caused by due to the devices were not fully tightened.Shavings came out from the nail / blade or broken condition were not observed in the videos.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the 10/125 deg ti cann tfna 400/right - sile would not contribute to the complained device issue.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 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: 10/125 DEG TI CANN TFNA 400/RIGHT - SILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• 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: 19704987
• Report Number: 8030965-2024-08404
• Device Sequence Number: 14365912
• Product Code: HSB
• UDI-Device Identifier: 10886982095886
• UDI-Public: (01)10886982095886
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.037.030S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - DRILL BITS: TRAUMA; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - NAILS: TFNA
• Patient Age: 87 YR
• Patient Sex: Female