MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR

Catalog Number	74018902
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a tka surgery, the impacting part of one (1) outer-grip locking fem implant impactor broke off from the handle.Additionally, it was noticed that its spring and bolt were lost.The procedure was resumed, without any delay, using a s+n back-up device.No pieces fell into the patient and no harm was reported as a consequence of this issue.
Additional Manufacturer Narrative
Section h3, h6: the associated device was returned and evaluated.The visual inspection revealed that the product was returned missing the impactor plate, the compression spring and the connecting dowel pin.The rest of the device showed signs of extensive wear and use but no fractures.This inspection was conducted by the naked eye.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device 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 risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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.
Additional Manufacturer Narrative
The associated device was returned and evaluated.The visual inspection revealed that the product was returned missing the impactor plate, the compression spring and the connecting dowel pin.The rest of the device showed signs of extensive wear and use but no fractures.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device 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 risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.However, it was determined that the work instruction that describes the assembly of this product indicates that both dowel pin holes shall be reamed using the drill press.Further investigation confirmed that this was an unapproved step in the assembly process as this caused out of tolerance measurements for the pin hole located on the drive shaft and an increased potential for the disassembly of the dowel pin and the impactor plate from the impactor.Therefore, this event can be confirmed and it was concluded that the cause of the reported incident was the unapproved assembly process of the pin to the drive shaft.At this time, we do have evidence to conclude that the product failed to meet specifications at the time of manufacture.This issue was identified and is being addressed though our internal quality process.Based on this investigation, the need for corrective action is 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: OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR
• 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: 19318908
• Report Number: 1020279-2024-00935
• Device Sequence Number: 7659101
• Product Code: HWA
• UDI-Device Identifier: 00885556697962
• UDI-Public: 00885556697962
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2025

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 Catalogue Number: 74018902
• Device Lot Number: 23FCT0007H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 06/11/2024; 05/12/2025
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/13/2024; 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2023
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: R-2025-01
• Patient Sequence Number: 1
• Patient Sex: Unknown