MAUDE Adverse Event Report: SYNTHES GMBH 9MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE; NAIL, FIXATION, BONE

Catalog Number 04.004.343

Device Problem Material Deformation (2976)

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

Event Date 12/07/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in colombia as follows: it was reported that on (b)(6) 2023, at the time of finishing the procedure, bending of the proximal part of the nail was observed.It was noted when releasing the connection screw there was binding, making it almost impossible to remove the screw.There was discomfort from the specialist, the procedure was achieved with success; however, the nail bending was not resolved.There was an additional surgery time of 20 minutes approximately with all the novelties presented during the procedure, there was no involvement of the patient.This report involves one (1) 9mm ti cannulated tibial nail-ex/315mm-sterile.This is report 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.D10: therapy date: december 7, 2023.E3: reporter is a j&j employee.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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.

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.H10 additional narrative: h3, h4, h6: part number: 04.004.343.Lot number: 6285p47.Manufacturing site: mezzovico.Release to warehouse date: 09 jun 2023.A manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances were identified.The product was not returned to depuy synthes, however photos were provided for review.The photo investigation did not found any evidence that can confirm the reported allegation.Images where reviewed, however more than one expert tn ø9 cann l315 tan dblue are observed, it is not possible to determine by photo quality the reported condition as lot number either isn't noticeable.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the expert tn ø9 cann l315 tan dblue 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 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: 9MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico CO 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18435276
• MDR Text Key: 331985172
• Report Number: 8030965-2024-00109
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K040762
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.004.343
• Device Lot Number: 6285P47
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: AIM-ARM F/TIB NAIL; AIM-ARM F/TIB NAIL; CONNECSCR CANN F/ETN F/SUPRAPATELLAR APP; UNK - SCREWDRIVERS; UNK - SCREWDRIVERS
• Patient Sex: Male