MAUDE Adverse Event Report: SYNTHES GMBH TIBIAL NAIL-ADVANCED / 10MM 375MM / STERILE; NAIL, FIXATION, BONE

Catalog Number	04.043.245S
Medical Device Problem Codes	Device-Device Incompatibility (2919); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
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.D2: additional procode: hwc.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: initial reporter is a synthes employee.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
Device report from the united kingdom reports an event as follows: it was reported that on (b)(6) 2024 during insertion of the nail, the poly inlay became stuck.The guidewire is in, the nail was inserted over the guidewire, and as the proximal end of the guidewire gets to the herzog bend it was forced to the back of the cannulation in the nail.The guidewire goes between the sleeve and the nail, but the sleeve is deformed and the surgeon cannot insert the nail.No further information is available.This report is for a tibial nail-advanced / 10mm 375mm / sterile.This is report 1 of 3 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.H11 additional narrative: h3, h6: the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that tibial nail advanced ø10 l 375 had the proximal inlay moved form his original position.The unable to assemble assemble allegation can be related to the movement of the inlay.No other defect can be observed on the photo evidence.According to the surgical technique: inlays made of polyetheretherketone (peek) in the nail provide angular stable locking in all screw holes, except for the dynamic and proximal static 2 locking holes.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the tibial nail advanced ø10 l 375 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 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: TIBIAL NAIL-ADVANCED / 10MM 375MM / STERILE
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18958260
• Report Number: 8030965-2024-03961
• Device Sequence Number: 15793822
• Product Code: JDS
• UDI-Device Identifier: 10886982297808
• UDI-Public: (01)10886982297808
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K201336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.043.245S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - GUIDE/COMPRESSION/K-WIRES; UNK - GUIDES/SLEEVES/AIMING: SLEEVE
• Patient Sex: Unknown