MAUDE Adverse Event Report: SYNTHES GMBH TIBIAL NAIL-ADVANCED / 9 330 / STERILE; NAIL, FIXATION, BONE

Model Number 04.043.130S

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6)2023, during the insertion of tibial nail advanced(tna) the surgeon noticed resistance around the area of the fracture.Surgeon pulled the nail out and proceeded to clean out that area pulling out a small piece of bone.Surgeon then reinserted the nail and again notice resistance.Surgeon pulled out the nail again and found the poly sleeve from our nail in the canal which would not allow the nail to be inserted fully.Surgeon then discarded that nail and fortunately had another nail of the same size and was then able to fully insert the nail and proceeded with the rest of the case.Procedure was completed successfully with a twenty(20) minutes of surgical delay.No patient consequences.This report is for one (1) tibial nail-advanced / 9mm 330mm / sterile this is report 1 of 2 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D9: complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment (wild tna sleeve.Jpg).Visual analysis of the photo revealed that the distal inlay of the tibial nail-advanced / 9 330 / sterile was heavily deformed.Photo evidence provided only shows the poly inlay component, it appears to have fallen apart from the nail as it is detached.As mentioned in the event description, the inlay fell apart inside the bone canal, resistance and failure to insertion of the nail is due to this condition.Since the nail is not visible in the image, it is not possible to perform a further investigation in order to trace a root cause for the reported condition.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the tibial nail-advanced / 9 330 / sterile.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: product code#:04.043.130s-us lot #:185p066 manufacturing site: (b)(6) release to warehouse date:23/06/2021 expiry date:31/05/2031 a manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.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 / 9 330 / 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: 16702720
• MDR Text Key: 313165934
• Report Number: 8030965-2023-04324
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982297624
• UDI-Public: (01)10886982297624
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.043.130S
• Device Catalogue Number: 04.043.130S
• Device Lot Number: 185P066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - GUIDES/SLEEVES/AIMING