MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEMORAL HEAD IMPACTOR (JAPAN)

Model Number	71362806
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case: (b)(4).The associated device was returned and evaluated. a visual inspection of the returned device did not confirm the stated failure mode.A visual inspection confirmed the tip is missing from the head of the device and was not returned.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A contribution of the devices to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
Event or Problem Description
It was reported that, during total hip replacement, the distal plastic tip of a femoral head impactor was cracked outside the patient.The surgeon was trying to remove a femoral head implant and the tip cracked.Based on the description provided by the initial reporter, there is no information that indicates that a separation of pieces occurred; however, a visual inspection confirmed the tip is missing from the head of the device and was not returned.It was confirmed that no pieces fell into the patient.Surgery was completed, without any delay, with a smith & nephew back-up device instead.Patient was not injured as consequence of this problem.

• Brand Name: FEMORAL HEAD IMPACTOR (JAPAN)
• Common Device Name: IMPACTOR
• 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: 15358633
• Report Number: 1020279-2022-03959
• Device Sequence Number: 1750323
• Product Code: HWA
• UDI-Device Identifier: 00885556025147
• UDI-Public: 00885556025147
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/05/2022

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: 71362806
• Device Catalogue Number: 71362806
• Device Lot Number: 20HM09147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 09/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown