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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAUMA & EXTREMITIES DEVICE; NAIL, FIXATION, BONE

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SMITH & NEPHEW, INC. TRAUMA & EXTREMITIES DEVICE; NAIL, FIXATION, BONE Back to Search Results
Catalog Number UNKNOWN
Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Impaired Healing (2378)
Event Date 06/01/2022
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: (b)(4).Abalkhail, t.B., elhessy, a.H., & conway, j.D.(2022).Removal of antibiotic cement-coated interlocking nails.Journal of orthopaedic trauma, 36(6), 317-320.Doi: 10.1097/bot.0000000000002287.
 
Event Description
It was reported that on literature review "removal of antibiotic cement-coated interlocking nails", one (1) patient suffered from failed bone transport over nail and was indicated for removal or exchange of the interlocking nailing system.The primary trigen interlocking nailing system was implanted with a coating of antibiotic cement and the potential to be permanent (off-label use of the implant).The current state of health of the patient is unknown.No further information is available.
 
Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the attached literature review on "removal of antibiotic cement-coated interlocking nails", was reviewed.However, based on the information provided, no further information is available.Consequently, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The photos provided in the article have been interpreted within the text; therefore, no further analysis of the photos are required.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 medical information be provided, this case 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 that could contribute to the reported event have been identified as excessive pressure on the joint, injury, procedural/user error, surgical/post operative complications, healing issues, patient condition, and/or user error.The contribution of the device to the reported event could not be corroborated.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.
 
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Brand Name
TRAUMA & EXTREMITIES DEVICE
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 Key15210376
MDR Text Key297702869
Report Number1020279-2022-03632
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 Literature,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/15/2022
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? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/26/2022
Initial Date FDA Received08/11/2022
Supplement Dates Manufacturer Received09/14/2022
Supplement Dates FDA Received09/15/2022
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;
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