MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 1-2 11MM; PAT-FEM-TIBIAL, SEMI-CNSTRND, CMNTD, POLY/METAL/POLY

Model Number	71420804
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).
Event or Problem Description
It was reported during the arthroscopy procedure that the genesis pe could not be inserted.The incident occurred inside the patient.The procedure was completed using a backup from smith & nephew.No patient injury or other complications were reported at the moment.
Event or Problem Description
It was reported during the arthroscopy procedure that the genesis pe could not be inserted.The incident occurred inside the patient.The procedure had a delay between 0-30 min and it was necessary to use a backup from smith & nephew.Although the surgeon blames the device, he was satisfied with the surgical outcome.No patient injury or other complications were reported.
Additional Manufacturer Narrative
Description of problem.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the returned device could not confirm the stated failure mode.The device has signs of damage from attempted use.A dimensional inspection of the returned device could not confirm or explain the stated failure mode.The device has signs of damage from attempted use.A dimensional inspection was attempted; the damage/deformation at several features of the device would not allow for accurate measurement.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.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 risk management files and instructions for use found that the reported failure was documented appropriately.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.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 complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII PS INSERT SZ 1-2 11MM
• Common Device Name: PAT-FEM-TIBIAL, SEMI-CNSTRND, CMNTD, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10934496
• Report Number: 1020279-2020-06912
• Device Sequence Number: 16361532
• Product Code: JWH
• UDI-Device Identifier: 03596010209511
• UDI-Public: 03596010209511
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2021

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: 71420804
• Device Catalogue Number: 71420804
• Device Lot Number: 19ET20840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 11/10/2020; 06/11/2021
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 12/17/2020; 06/16/2021
• 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: Required Intervention