MAUDE Adverse Event Report: SYNTHES GMBH TIBIAL NAIL-ADVANCED / 11MM 300MM / STERILE; NAIL, FIXATION, BONE

Catalog Number 04.043.320S

Device Problems Break (1069); Device-Device Incompatibility (2919)

Patient Problem Insufficient Information (4580)

Event Date 11/29/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that on november 29, 2023, the patient underwent surgery for a tibial diaphyseal fracture with the tna.In the surgery, the drill tip in question interfered with the nail when drilling the ap hole during fixation of the distal lateral stop screw.It is possible that the inlay was slightly shaved off in doing so.The direction of the drill tip was changed, drilling was performed again, and the screw insertion was successfully completed.The surgeon confirmed that there were no pieces in the patient¿s body.This report involves one tibial nail-advanced / 11mm 300mm / sterile.This is report 2 of 2 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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.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.

• Brand Name: TIBIAL NAIL-ADVANCED / 11MM 300MM / 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: 18372050
• MDR Text Key: 331378231
• Report Number: 8030965-2023-16012
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 07612334171641
• UDI-Public: (01)07612334171641
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Physician
• Type of Report: Initial

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: 04.043.320S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/21/2023
• 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: DRILL BIT Ø4.2 CALIBR L145 3FLUTE W/COUP; UNK - SCREWS: TRAUMA