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

Catalog Number UNKN02200602

Device Problem Migration (4003)

Patient Problem Perforation (2001)

Event Date 05/01/1998

Event Type  Injury  

Event Description

On the literature article name "intramedullary fixation of high subtrochanteric femoral fractures: a study comparing two implant designs, the gamma nail and the intramedullary hip screw", it was reported that, on the imhs group, 1 patient had the tip of the head screw penetrated the acetabulum four months after surgery, secondary to the failure of screw sleeve locking, since the sleeve had become loose and migrated outward.It is unknown if / how the adverse event was resolved.Patient outcome is unknown.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event 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, 1 patient had the tip of the head screw penetrated the acetabulum four months after surgery, secondary to the failure of screw sleeve locking, since the sleeve had become loose and migrated outward.It is unknown if /how the adverse event was resolved.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 product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing, lack of ingrowth and/or traumatic injury.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: 12388684
• MDR Text Key: 268875412
• Report Number: 1020279-2021-06609
• 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: 10/15/2021

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: UNKN02200602
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 08/30/2021
• Supplement Dates Manufacturer Received: 10/14/2021
• Supplement Dates FDA Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention