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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. UNKN TRAUMA & EXTREMITIES DEV; NAIL, FIXATION, BONE Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Non-union Bone Fracture (2369); Skin Disorders (4543)
Event Date 05/25/2022
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference (b)(4).Article cite: conway, j.D., elhessy, a.H., galiboglu, s., patel, n., & gesheff, m.G.(2022).Efficacy of infection eradication in antibiotic cement-coated intramedullary nails for fracture-related infections, nonunions, and fusions.Antibiotics (basel, switzerland), 11(6), 709.Https://doi.Org/10.3390/antibiotics11060709.
 
Event Description
It was reported that on literature review, "efficacy of infection eradication in antibiotic cement-coated intramedullary nails for fracture-related infections, nonunions, and fusions", 7 patients (out of 111) had not achieved healed or uninfected bone or stable arthrodiesis, at the time of the study, after having a primary antibiotic cement-coated intramedullary nail procedure (accin).As reported, these patients were still under treatment for nonunion at the time of the study.The type of treatment is unknown as well as the outcome of the patients.The primary accin procedures were performed for the treatment of infected nonunions or infected arthrodeses.Patient´s outcome is unknown.No further information is available.
 
Manufacturer Narrative
H3, h6: the devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per the complaint, no further information will be provided.Consequently, 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.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.The contribution of the devices 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 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.
 
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Brand Name
UNKN TRAUMA & EXTREMITIES DEV
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 Key15108396
MDR Text Key296656303
Report Number1020279-2022-03481
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 Study,Literature,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/26/2022
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
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/07/2022
Initial Date FDA Received07/26/2022
Supplement Dates Manufacturer Received08/25/2022
Supplement Dates FDA Received08/26/2022
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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