MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.0MM X 13MM LCK SCR T6 S-T; PLATE, FIXATION, BONE

Model Number	72412013
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, two (2) evos 2.0mm x 13mm lck scr t6 s-t was noticed broken while surgeon was putting them into plate.Surgery was resumed, without any delay, with s+n back-up devices.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The associated devices were returned and evaluated.A visual inspection of the returned devices reveal pieces of the threads are broken off.The broken pieces were not returned.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.Based on the conclusions of the product history review, complaint history review and the device evaluation, further product evaluation is not required because there is no evidence that a manufacturing deficiency occurred.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management and information for use files revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.According to the material specification, the quality and manufacture of special quality stainless steel bar, strip, and coil stock shall be controlled.Factors that could contribute to the reported event include surgical technique or excessive forces applied.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.

• Brand Name: EVOS 2.0MM X 13MM LCK SCR T6 S-T
• Common Device Name: 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 Key: 16924706
• Report Number: 1020279-2023-01026
• Device Sequence Number: 6920784
• Product Code: HRS
• UDI-Device Identifier: 00885556426395
• UDI-Public: 00885556426395
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K210837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72412013
• Device Catalogue Number: 72412013
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown