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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN EVOS PLATING SCREW; PLATE, FIXATION, BONE

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SMITH & NEPHEW, INC. UNKNOWN EVOS PLATING SCREW; PLATE, FIXATION, BONE Back to Search Results
Catalog Number UNKNOWN
Device Problem Fracture (1260)
Patient Problems Perforation (2001); Device Embedded In Tissue or Plaque (3165)
Event Date 10/10/2023
Event Type  Injury  
Event Description
It was reported that, during an internal fixation surgery, a 2.0mm unknown evos plating screw was inserted into a mid shaft ulna and upon inserting the screw on power to finish seating with hand tightening the head of the screw broke off.The broken piece was removed, but the rest of the broken screw was left inside the patient.It is unknown if there were any delays to the surgery due to this issue, but the procedure was completed using evos mini 2.4 mm screws.No patient injury was reported due to this issue.
 
Manufacturer Narrative
H10: internal complaint reference: (b)(4).
 
Manufacturer Narrative
H3, h6: the devices sent by the costumer were returned and evaluated.Although the screws provided were not directly involved in the complaint case, similar screws in terms of size and specification were provided.A review made by the quality engineering team revealed that, upon investigation, it was discovered that all six parts provided by the sales representative were within the tolerance outlined in the drawing print.The clinical/medical investigation concluded that, based on the limited information provided, the definitive clinical root cause of the reported breakage could not be determined.Although a procedure vs user error could not be rule out as a contributory factor.The evos screws are made of 318 stainless steel, and they are used to fix the plate to the bone, inside the patient.According to the report, the body of the screw was left secured in the patient's bone, therefore, the possibility of micro-motion and/or migration is unlikely.The surgeon completed the procedure with a evos mini 2.4mm screw in a new bone hole without any injury to the patient, however, it is unclear if there was a delay in the procedure.The impact to the patient was the retained screw.Should any additional relevant medical information be provided, this case would be re-assessed.A review of the instructions for use documents for evos plating system revealed that loosening, bending, cracking or fracture of implant components has been identified in the adverse effects.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, risk management file, prior actions and product prints could not be performed.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique and/or user error.Based on this investigation, the need for corrective action is not indicated.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.Corrected data: h6 (health effect - impact code).
 
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Brand Name
UNKNOWN EVOS PLATING SCREW
Type of Device
PLATE, 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 Key18737789
MDR Text Key335736231
Report Number1020279-2024-00403
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140814
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/08/2024
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 10/10/2023
Initial Date FDA Received02/20/2024
Supplement Dates Manufacturer Received04/05/2024
Supplement Dates FDA Received04/08/2024
Was Device Evaluated by Manufacturer? No
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) Other;
Patient Age41 YR
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