MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII ART INS SPCR TRL 1-2 15MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71430332
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a consignment inspection the device was found with burrs/nicks/scratches/gouges.No patient was involved.The investigation found that the trial was cracked.

• Brand Name: GII ART INS SPCR TRL 1-2 15MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12088663
• Report Number: 1020279-2021-05551
• Device Sequence Number: 3235934
• Product Code: LXH
• UDI-Device Identifier: 03596010481283
• UDI-Public: 03596010481283
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: 71430332
• Device Catalogue Number: 71430332
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 08/26/2021
• Patient Sequence Number: 1