MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 OFFSET IMPACTOR TIP; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71363077

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2020

Event Type  Injury  

Event Description

It was reported that during thr procedure the r3 offset impactor tips broke while impacting.This happened during use inside the patient.All pieces recovered, nothing left in patient.There was a s&n back up device to complete the procedure.The patient outcome is normal.There was no delay.The broken pieces were discarded by the account.No patient injury /impact reported at this time.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: R3 OFFSET IMPACTOR TIP
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 10813409
• MDR Text Key: 215461026
• Report Number: 1020279-2020-06295
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010599391
• UDI-Public: 03596010599391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

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
• Device Operator: Health Professional
• Device Model Number: 71363077
• Device Catalogue Number: 71363077
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 08/16/2021
• Supplement Dates FDA Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention