MAUDE Adverse Event Report: SMITH & NEPHEW, INC. G2 P/S ART TR SZ5-6 9MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	71430829
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure the tibial trial broke.No delay or injury reported.A back up device was available.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of the manufacturing records for the listed batch 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.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: G2 P/S ART TR SZ5-6 9MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8547074
• Report Number: 1020279-2019-01655
• Device Sequence Number: 2443770
• Product Code: LXH
• UDI-Device Identifier: 03596010213495
• UDI-Public: 03596010213495
• 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): 10/20/2019

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 Catalogue Number: 71430829
• Device Lot Number: 12E1416852
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 10/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1