MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII CR DEEP FLEX ISR TR S1-2 9; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	71430442
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the insert trial broke during use.S&n backup was available.All pieces recovered.No delay to the procedure, no injury to the patient.The device will be returned.No closure letter needed.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection confirms the trial has fractured into two pieces.Both pieces were returned.The device also has multiple scratches, burrs and gouges in the plastic.The device shows extreme signs of wear/usage.The device was manufactured in 2009.A review of complaint history on the listed part revealed no prior complaints for the listed batch number with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.

• Brand Name: GII CR DEEP FLEX ISR TR S1-2 9
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9142436
• Report Number: 1020279-2019-03531
• Device Sequence Number: 11208293
• Product Code: LXH
• UDI-Device Identifier: 03596010001375
• UDI-Public: 03596010001375
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2019

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: 71430442
• Device Lot Number: UNKNOWN/UNREADABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 11/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1