MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CHP TITAN 95 LNGTH 16 THD; APPLIANCEFIXATIONNAILBLADEPLATECOMBINATIONMULTIPLECOMPONENT

Model Number	71102095
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during surgery, the screw of the chp titan 95 lngth 16 thd was spinning and it was not tightened.Screw shaft is not straight.Using back up smith and nephew device, the surgery was completed.There was a 10-minute surgical delay.The patient was not harmed.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device's screw shaft was found to to slightly bent, rendering the device inoperative.However, the looseness of the device could not be confirmed.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device 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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This issue was evaluated through our internal quality process and determined to be potentially caused by poor handling or insertion.A review of the risk management file 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.The contribution of the device to the reported event could not be corroborated.Some potential probable causes for this event could include surgical technique or insertion technique.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: CHP TITAN 95 LNGTH 16 THD
• Common Device Name: APPLIANCEFIXATIONNAILBLADEPLATECOMBINATIONMULTIPLECOMPONENT
• 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: 14408048
• Report Number: 1020279-2022-02382
• Device Sequence Number: 20212114
• Product Code: KTT
• UDI-Device Identifier: 03596010460400
• UDI-Public: 03596010460400
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2022

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: 71102095
• Device Catalogue Number: 71102095
• Device Lot Number: 17HT91466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Sex: Unknown