MAUDE Adverse Event Report: SYNTHES GMBH TIBIAL NAIL ADVANCED Ø10 L315; NAIL, FIXATION, BONE

Catalog Number 04.043.225S

Device Problems Contamination /Decontamination Problem (2895); Device-Device Incompatibility (2919); Difficult to Advance (2920)

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

Event Date 03/14/2023

Event Type  malfunction  

Event Description

Device report from synthese reports an event in the uk as follows: it was reported on (b)(6) 2023, the tibial nail had difficulties being put in a patient with a comminuted distal fracture.The nail jammed over the ball tip guidewire, with a piece of cortical bone trapped inside the peek insert.On removal of the nail the peek had also fragmented and it wasn¿t possible to remove the guidewire from the nail.The reaming was carried out in the proximal fragment.This report is for one (1) tibial nail advanced ø10 l315 this is report 1 of 1 product complaint # (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Additional narrative: reporter is a j&j employee.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.D4: expiration date h3, h4, h6: product code: 04.043.225s.Lot # 657p221.Manufacturing site: jabil bettlach.Release to warehouse date:07/03/2022.Expiry date:01/02/2032.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that the distal end of tibial nail advanced ø10 l315, p/n: 04.043.225s, appears to be assembled to the guide wire.Between the two devices, there appears to be foreign substance.The assembly allegations can not be confirmed as the device was not returned for evaluation.Functionality issues can not be evaluated through a photo investigation.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 tibial nail advanced ø10 l315, p/n: 04.043.225, lot: 657p221.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 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 Ø10 L315
• 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: 16664387
• MDR Text Key: 312913172
• Report Number: 8030965-2023-04007
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 07612334171504
• UDI-Public: (01)07612334171504
• 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,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.043.225S
• Device Lot Number: 657P221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - GUIDE/COMPRESSION/K-WIRES