MAUDE Adverse Event Report: SYNTHES GMBH ELBOW HINGE FIXATOR; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 394.055

Device Problems Break (1069); Device Slipped (1584)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/27/2021

Event Type  Injury  

Manufacturer Narrative

Additional product code: lxt.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.(b)(4).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 (b)(6) as follows: it was reported that on (b)(6) 2021, the sales rep got the information that the clasp part of the hinged joint rod for external fixator got loose and the hinged joint rod got loose and disassembled.On (b)(6) 2021, similar event occurred, and a hinged joint rod replaced with new one (this event was reported in (b)(4)).But this time, exactly the same event occurred again.New hinged joint rod was urgently arranged again and provided on (b)(6).Initially, the condition of the patient¿s elbow was to be confirmed next week to determine whether to remove the external fixator.The surgeon hastened the timing of determination than planned due to this event.Patient did not have dislocation, and the condition was judged to be stable, and the external fixator was removed.External fixation was performed, and the patient was followed up.Procedure was completed successfully without any delay.Concomitant devices reported: unk - rods (part# unknown; lot# unknown; quantity: unknown).Unk - clamp (part# unknown; lot# unknown; quantity: unknown).Unk - wrenches (part# unknown; lot# unknown; quantity: unknown).This report is for one (1) elbow hinge fixator.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, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.H6 - codes updated to imdrf codes.Note: the complaint device was evaluated and investigated by the manufacturing site: jabil bettlach and the materials lab in oberdorf.Please refer to the attachments "attached to (b)(4) results to pi-16225571480274158" and "mat3987_en" for the respective reports.The product was returned to depuy synthes and sent to manufacturing site: jabil bettlach and materials lab: oberdorf for evaluation.The jabil bettlach and oberdorf teams conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that hinged joint rod f/ext- was received disassembled.Traces of use and scratches were visible on the surface.Adhesive residues or other contaminants are on hinged joint pieces, on the thread of the nut and on the thread of the tubular rivet.The adhesive was analyzed with ftir-method and found to coincide with the spectra of acrylate, usually used in the composition of adhesive tape, adhesive base of labels or packaging materials.The studies show that the foreign substance is not a structural part of the base material.The affected product under study possibly was contaminated with the foreign substance during manufacturing or handling process.The substance is not an epoxy resin.A functional test cannot be performed because of the returned condition of the device.The received hinged joint rod f/ext- was not assembled anymore.The dimensional inspection was performed, and it is within the specification limit.The thread was cleaned to remove the residues of the adhesive.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for that hinged joint rod f/ext.While no definitive root cause could be determined, there is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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.Drawing/specifications reviewed- the following drawing reflecting the current and manufacture revision was reviewed.Dimensional inspection: dimensional inspection was performed for the design of device.Device history lot - part: 394.055 lot: 70p8112 manufacturing site: bettlach release to warehouse date: 13.October 2020 a manufacturing record evaluation was performed for the finished article lot and no non-conformances were 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: ELBOW HINGE FIXATOR
• 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): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12056819
• MDR Text Key: 258025591
• Report Number: 8030965-2021-05281
• 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: K063832
• 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,Followup,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 394.055
• Device Lot Number: 70P8112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/13/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - RODS; UNK - WRENCHES; UNK CLAMP; UNK - RODS; UNK - WRENCHES; UNK CLAMP
• Patient Outcome(s): Required Intervention