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 No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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 history lot: a manufacturing record evaluation was performed for the finished good lot and no non-conformance's 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.

Event Description

This pc is related to (b)(4).It was reported that, 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.On the same day, the hinged joint rod was replaced with new one.But on (b)(6) the hinge part of the hinged joint rod was loosened again.The surgeon tightened the hinge part and was following up the patient.Concomitant devices reported: unknown plate (part# unknown, lot# unknown, quantity 1).This report is for one (1) elbow hinge fixator.This is report 1 of 1 for complaint (b)(4).

• 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: 12313280
• MDR Text Key: 266242065
• Report Number: 8030965-2021-06594
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819815070
• UDI-Public: (01)07611819815070
• Combination Product (y/n): N
• PMA/PMN Number: K063832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• 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: 117P041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1