MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN COMPASS HINGE ELBOW DISTRACTOR; PIN, FIXATION, THREADED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Necrosis (1971)

Event Type  Injury  

Event Description

"treatment of unreduced elbow dislocations with hinged external fixation".Author: jesse b.Jupiter, md, et al., published by the journal of bone and joint surgery, incorporated.According to the study, a total of 5 patients with an unreduced dislocation of the elbow without associated fractures were treated with open relocation of the joint and hinged external fixation at an average of eleven weeks (range, six to thirty weeks) after the initial injury, using for external fixation compass hinge elbow distractor; smith and nephew, memphis, tennessee) it was documented on the paper that one patient had development of a small zone of blistering of the medial flap that resulted in a small amount of superficial skin necrosis, the blisters healed with dressing changes.

Manufacturer Narrative

It was reported from a literature review that the patient had developed a small zone of blistering of the medial flap that resulted in a small amount of superficial skin necrosis.The blisters healed with dressing changes.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.Based on this investigation, the need for corrective action is not indicated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.

• Brand Name: UNKNOWN COMPASS HINGE ELBOW DISTRACTOR
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10049719
• MDR Text Key: 190740886
• Report Number: 1020279-2020-01640
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Distributor Facility Aware Date: 04/15/2020
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention