MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SPC FIXED PS HOUSNG COL 2; PROST, KNEE, PAT/FEMTIB, SEMI-CONST, UNCEMENT, POROUS, COATED, POLY/MET/POLY

Model Number	71440003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the procedure, when the surgeon went to unscrew the size 1-2 legion reamer collet, the screw that threads into the femoral component broke off.The broken piece did not fall inside the patient, and all parts were retrieved.The procedure was completed without delay and backup from smith & nephew was available to finished the surgery.There are no reports/adverse events to document with this incident.
Additional Manufacturer Narrative
H3,h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was found to be fractured.The fractured pieces were returned.The device was manufactured in 2011 and shows signs of extensive use.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 complaint history did not reveal additional complaints for the listed batch.At this time, we do not have reason to suspect that the product failed to meet any product 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 probable causes of 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.

• Brand Name: GII SPC FIXED PS HOUSNG COL 2
• Common Device Name: PROST, KNEE, PAT/FEMTIB, SEMI-CONST, UNCEMENT, POROUS, COATED, POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10795873
• Report Number: 1020279-2020-06248
• Device Sequence Number: 17058107
• Product Code: MBH
• UDI-Device Identifier: 00885556033906
• UDI-Public: 00885556033906
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2020

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: 71440003
• Device Catalogue Number: 71440003
• Device Lot Number: 11MAB0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1