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

Catalog Number UNKN02200602

Device Problem Failure to Align (2522)

Patient Problems Perforation (2001); Deformity/ Disfigurement (2360)

Event Date 02/18/2010

Event Type  Injury  

Event Description

On the literature article named "comparing two intramedullary devices for treating trochanteric fractures: a prospective study", the authors of the study reported that, when treating patients with the imhs system for a peri trochanteric fracture, one patient suffered from a cut-out associated with malposition of the proximal lag screws.The case was treated with reoperation using the imhs nail without any further complication.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, the data presented in the aged article it was reported when treating patients with the imhs system for a peri trochanteric fracture, one patient suffered from a cut-out associated with malposition of the proximal lag screws.The case was treated with re-operation using the imhs nail without any further complication.Per the complaint, under the master case-2021-00068877, no further information will be provided.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded.In addition, the physician referenced in the abstract provided an analysis of all the attached images.Therefore, no further interpretation of the attached images is required.No further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A potential probable cause for this event could include but not limited to post op complications.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device 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: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12388490
• MDR Text Key: 268879525
• Report Number: 1020279-2021-06605
• Device Sequence Number: 1
• Product Code: HWC
• 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: 10/14/2021

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: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKN INTRAMEDULLARY HIP SCREW (IMHS) NAIL
• Patient Outcome(s): Hospitalization; Required Intervention