MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANN SC 30MM TITANIUM 4.0; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	71101030
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during use outside the patient, 4.0mm cannulated screw head opened from a new box.Found out that the head was round, instead of conventional hexagonal shape.The procedure finished with change in a surgical technique.No surgical delay.Patient injuries were not reported.
Additional Manufacturer Narrative
H3, h6: the associated device ,used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The hex feature is missing from the head of the device, rendering it inoperable.The device shows no signs of use.The clinical medical investigation concluded that, based on the information provided, this out of the box failure was identified prior to patient use.Per report, the surgeon was able to finish the procedure with change in a surgical technique.Since there was no surgical delay or patient injuries reported, no further clinical/medical assessment is warranted at this time.Should additional medical information be provided, this complaint will be re-assessed.A review of complaint history for the listed part revealed no prior complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have reason to suspect that the product failed to meet product specifications at the time of manufacture.A review of the instructions for use document revealed this failure mode was previously identified.The potential probable cause for this event is a manufacturing process error.This issue was evaluated through our internal nonconformance process and determined to be isolated at this time.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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: CANN SC 30MM TITANIUM 4.0
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10881931
• Report Number: 1020279-2020-06628
• Device Sequence Number: 16823288
• Product Code: KTT
• UDI-Device Identifier: 03596010437242
• UDI-Public: 03596010437242
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K993289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71101030
• Device Catalogue Number: 71101030
• Device Lot Number: 20FM03687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 11/22/2020
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention