MAUDE Adverse Event Report: SYNTHES GMBH HINGED JOINT ROD F/EXT-FIX; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 394.055

Device Problem Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 08/29/2023

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.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 expected to be returned for manufacturer review/investigation but has yet to be received.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.

Event Description

Device report from synthes reports an event in japan as follows: it was reported that the external fixation was performed in the proximal ulnar surgery for hallux valgus fracture, and the product in question was placed on elbow on (b)(6) 2023.The surgery was completed successfully without any surgical delay.On (b)(6) 2023, the screw of the hinge part of the said product loosened, and the fixation broke down.The surgeon used a flat-blade screwdriver in the hospital to retighten the screws.The removal surgery was scheduled on (b)(6) 2023, but it was performed on (b)(6) 2023, to remove the external fixation.The surgery was completed successfully without any surgical delay.The surgeon commented ¿i know that due to the construction of the hinge on the elbow fix, it could come loose, but is this common to occur? how tight should they be if they are to be re-tightened?¿ the product in question was new and there is no indication in the procedure manual that it needs to be retightened.No further information is available.This report is for one (1) hinged joint rod f/ext-fix.This is report 1 of 1 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.H3, h4, h6 investigation summary product was not returned.Based on the information available, it has been determined that no corrective and 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 history a manufacturing record evaluation was performed for the finished device product code: 394.055-15, lot number : 1653p23, it was electronically reviewed and no non conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 19/09/2022, manufacturing site: jabil bettlach.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: HINGED JOINT ROD F/EXT-FIX
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): JABIL BETTLACH; muracherstrasse 3; bettlach CO 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 17744383
• MDR Text Key: 323386055
• Report Number: 8030965-2023-11547
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819815070
• UDI-Public: (01)07611819815070
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090658
• 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: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 394.055
• Device Lot Number: 1653P23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1