MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TIN 5MM X 45MM SHORT HALF PIN; PIN, FIXATION, THREADED

Model Number	71065458
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during internal fixation surgery, (2) jet-x tin 5mm x 45mm short half pins broke off in the femur.It is unknown if/how surgery was completed, and if there was any delay.No patient injury reported at this time.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during internal fixation surgery, (2) jet-x tin 5mm x 45mm short half pins broke off in the femur.It is unknown if/how surgery was completed, and if there was any delay.No patient injury reported at this time.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.A visual inspection of the returned devices confirmed the stated failure mode.Two of the three devices that were returned were fractured along the threaded area, rendering the devices inoperable.It is unknown if the third device was used or not.A review of complaint history revealed similar events for the listed devices over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.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 products failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document 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 these devices and failure mode.A contribution of the devices to the reported event could be corroborated as the devices were found to be fractured.Damage from misuse or rough handling are likely probable causes of the reported event.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.

• Brand Name: TIN 5MM X 45MM SHORT HALF PIN
• Common Device Name: PIN, FIXATION, THREADED
• 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: 13476730
• Report Number: 1020279-2022-00535
• Device Sequence Number: 14727693
• Product Code: JDW
• UDI-Device Identifier: 03596010487315
• UDI-Public: 03596010487315
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K023134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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: 71065458
• Device Catalogue Number: 71065458
• Device Lot Number: 21DSZ0034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown