MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN INTRAMEDULLARY HIP SCREW (IMHS) SCREW; NAIL, FIXATION, BONE

Catalog Number UNKN02200602

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

Patient Problem Hip Fracture (2349)

Event Date 05/01/1998

Event Type  Injury  

Event Description

On the literature article named "intramedullary versus extramedullary fixation for the treatment of intertrochanteric hip fractures", the authors of the study reported that, 2 patients from the imhs group, had the lag screw that cut out from the femoral head.Additional details about this event are unknown.

Manufacturer Narrative

The devices, used in treatment, were not returned for evaluation and the reported events could not be confirmed.The clinical/medical investigation concluded that, the data presented in the aged article on the, ¿intramedullary versus extramedullary fixation for the treatment of intertrochanteric hip fractures", reported, 2 patients from the imhs group, had the lag screw that cut out from the femoral head.Additional details about this event are unknown.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should any additional relevant patient information be provided, this complaint would be re-assessed.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported events have been identified as overuse or excessive pressure on the joint, injury and/or patients condition.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN INTRAMEDULLARY HIP SCREW (IMHS) SCREW
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12388921
• MDR Text Key: 268878984
• Report Number: 1020279-2021-06621
• Device Sequence Number: 1
• Product Code: JDS
• 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: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN02200602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention