MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXINIUM FEMORAL IMPACTOR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71440890
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, a genesis ii oxinium femoral impactor broke.Incident occurred during a tka with instruments inside the patient.All the pieces were removed.The procedure was successfully completed without delay using a back-up device.No other complications were reported.No patient information neither operative reports are available.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.The visual inspection confirms the impactor head broke off the device.This piece was returned with the device.This device shows signs of significant wear/usage.The device was manufactured in 2005.A medical investigation was conducted and confirms this case reports the femoral impactor broke during use inside the patient.Per email correspondence, all pieces were removed, and the procedure was completed successfully using a backup device without delay.No further clinical assessment is warranted.A review of complaint history on the listed part revealed no prior complaint for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities 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.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.Internal complaint reference number: (b)(4).

• Brand Name: GII OXINIUM FEMORAL IMPACTOR
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11403059
• Report Number: 1020279-2021-01770
• Device Sequence Number: 4568645
• Product Code: JDI
• UDI-Device Identifier: 03596010476074
• UDI-Public: 03596010476074
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

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: 71440890
• Device Catalogue Number: 71440890
• Device Lot Number: 05FM07919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention