MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5MM M-P TIBIA PL 8H R 117MM; PLATE, FIXATION, BONE

Model Number	72463808
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an internal fixation procedure, it was found that the evos 3.5mm m-p tibia pl 8h r 117mm peel pack inside was not sealed.Surgery was resumed, with a non-significant delay, using a competitor's device.Patient was not harmed.No further complications reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Section h10: the associated device was returned and evaluated.A relationship between the device and the reported event could be corroborated, as the visual inspection of the returned device confirmed the device's packaging was found to be unsealed.Therefore, the product did not meet manufacturing specifications upon distribution.This issue was evaluated through our internal quality process which concluded the root cause to be an isolated human error in the heat seal operation, due to the manual nature of the packaging process.There is no evidence that other product within the lot as affected.No additional complaints have been received for this manufacturing lot to date.Additionally, for the detection of this defect, the product is visually inspected 100%.This reduces the risk of other orders being affected.A review of complaint history for the part number over the past 12 months did not reveal similar events for the listed device.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the sterilization records revealed the batch was sterilized within normal parameters.A review of the risk management file revealed this failure mode was previously identified and 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.A quality alert communication was provided to manufacturing personnel to prevent recurrence.Based on this investigation, the need for additional 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.Internal complaint reference number: (b)(4).

• Brand Name: EVOS 3.5MM M-P TIBIA PL 8H R 117MM
• 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: 14639364
• Report Number: 1020279-2022-02816
• Device Sequence Number: 4904625
• Product Code: HRS
• UDI-Device Identifier: 00885556644751
• UDI-Public: 00885556644751
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K170457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2022

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: 72463808
• Device Catalogue Number: 72463808
• Device Lot Number: 18JM08002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2018
• 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