MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEMORAL IMPACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	00133602800
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).
Event or Problem Description
It was reported that during tka procedure the tip of the femoral impactor broke off during impaction (inside the patient).All pieces have been recovered.No harm to patient or staff.There as no delay.Procedure concluded with a s&n back up device.No other complications reported at this time.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection confirmed the tip broke off the femoral impactor.The device shows significant signs of wear/usage.A medical investigation was conducted and confirms per complaint details, during the tka the device tip broke with impaction; however, the case was reportedly finished with a s+n backup device without reported patient harm or a surgical delay.No further complications were reported.Responses to medical documentation/information requests were not provided as of the time of this assessment.The clinical root cause could not be definitively concluded.The product evaluation will be performed and reported independent of the medical investigation.Patient impact beyond the reported use of a backup device to complete the procedure would not be anticipated as no injury or surgical delay/other complications were alleged.No further medical assessment is warranted at this time.A complaint history review found related failures; 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.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instruments that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause 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.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: FEMORAL IMPACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11094898
• Report Number: 1020279-2020-08015
• Device Sequence Number: 3698391
• Product Code: LXH
• UDI-Device Identifier: 00885556618738
• UDI-Public: 00885556618738
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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: 00133602800
• Device Catalogue Number: 00133602800
• Device Lot Number: 61030216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1