MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT TR S1-2 11; TRAY, SURGICAL, INSTRUMENT

Model Number	71430402
Medical Device Problem Codes	Fracture (1260); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during consignment inspection the device was found with burrs and nicks.Device will be returned.After investigation, upon product's receipt, it has been confirmed that the device is cracked/broken.

• Brand Name: GII PS HI FLEX ISRT TR S1-2 11
• Common Device Name: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 11285084
• Report Number: 1020279-2021-01014
• Device Sequence Number: 14327801
• Product Code: FSM
• UDI-Device Identifier: 03596010493026
• UDI-Public: 03596010493026
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/28/2021

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 Expiration Date: 01/01/2020
• Device Model Number: 71430402
• Device Catalogue Number: 71430402
• Device Lot Number: 08EM07578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 02/28/2021
• Patient Sequence Number: 1