MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT TR S1-2 9; TRAY, SURGICAL, INSTRUMENT

Model Number	71430401
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a consignment inspection the device was found with corrosion/discoloration.The device will be returned.The investigation found that there were little pieces breaking off in certain areas.

• Brand Name: GII PS HI FLEX ISRT TR S1-2 9
• Common Device Name: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11642972
• Report Number: 1020279-2021-02813
• Device Sequence Number: 3157382
• Product Code: FSM
• UDI-Device Identifier: 03596010493019
• UDI-Public: 03596010493019
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 05/05/2021

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: 71430401
• Device Catalogue Number: 71430401
• Device Lot Number: 09BM21230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 05/05/2021
• Patient Sequence Number: 1