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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL IMPL; NAIL, FIXATION, BONE

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SMITH & NEPHEW, INC. UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL IMPL; NAIL, FIXATION, BONE Back to Search Results
Catalog Number UNKNOWN
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)
Event Date 01/31/2022
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that, seven (7) months after internal fixation surgery was conducted to repair a right peritrochanteric femur fracture, there was a subtrochanteric non-union with failed fixation for removal of deep broken right femur hardware.
 
Manufacturer Narrative
H10: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The end of the device is missing paint and broken, rendering the device inoperative.The clinical/medical evaluation concluded that this complaint was reported via medwatch.However, neither the requested relevant clinical information nor the device was provided.Therefore, a thorough medical investigation cannot be rendered nor could a definitive clinical root cause of the reported failure be determined.The impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.As the device broke and it cannot longer fit its purpose, the contribution of the device to the reported event could be corroborated.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, or injury.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.Internal complaint reference number: (b)(4).
 
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Brand Name
UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL IMPL
Type of Device
NAIL, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key13935759
MDR Text Key288175064
Report Number1020279-2022-01387
Device Sequence Number1
Product Code JDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 04/22/2022
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 NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/07/2022
Initial Date FDA Received03/29/2022
Supplement Dates Manufacturer Received04/21/2022
Supplement Dates FDA Received04/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 YR
Patient SexMale
Patient Weight97 KG
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