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

Catalog Number 04.043.245S

Device Problems Device-Device Incompatibility (2919); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 03/05/2024

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.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 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).

• Brand Name: TIBIAL NAIL-ADVANCED / 10MM 375MM / STERILE
• Type of Device: 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
• MDR Text Key: 338461045
• Report Number: 8030965-2024-03961
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982297808
• UDI-Public: (01)10886982297808
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K201336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.043.245S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - GUIDE/COMPRESSION/K-WIRES; UNK - GUIDES/SLEEVES/AIMING: SLEEVE