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

Catalog Number 394.055

Device Problem Device Slipped (1584)

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

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the osteosynthesis surgery for elbow fracture with the hinged joint rod in question.During the surgery, a plate was implanted, and the elbow hinge fixator was used additionally.On (b)(6), the hinge part of the hinged joint rod was loosened and on the same day, the hinged joint rod was replaced with new one.This event is the same as (b)(4).Concomitant device 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.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.H3, h6: product code: 394.055, lot: 25p5914, manufacturing site: bettlach, release to warehouse date: january 09, 2020, expiry date: n/a.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.The product was returned to us customer quality (cq) for evaluation.The us cq team forwarded the device to the manufacturing investigation for further investigation.Visual analysis of the returned sample revealed that hinged joint rod f/ext-fix the device was disassembled and received as separate components.Traces of use and scratches were visible on the surface.Adhesive residues or other contaminants are on the thread of the nut.The dimensional inspection was performed, and it is within specification limit.The observed condition of hinged joint rod f/ext-fix in the device was consistent with the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for hinged joint rod f/ext-fix.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: dynamic elbow fixator.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
• MDR Report Key: 12299994
• MDR Text Key: 265781720
• Report Number: 8030965-2021-06541
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819815070
• UDI-Public: (01)07611819815070
• Combination Product (y/n): N
• PMA/PMN Number: K090658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 25P5914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 08/10/2021; 09/09/2021; 10/06/2021
• Supplement Dates FDA Received: 08/10/2021; 09/09/2021; 10/06/2021
• Patient Sequence Number: 1
• Treatment: UNK - CLAMP; UNK - RODS; UNK - WRENCHES
• Patient Outcome(s): Required Intervention