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

Model Number	71430442
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the genesis ii cr deep flex isr tr s129 insert has cracked while it was being inserted.No injuries or surgical delays were reported.An s and n backup device was available.
Additional Manufacturer Narrative
The device, used in treatment was returned for evaluation.Visual inspection of the returned device shows wear and tear from use and it was damaged and broken.The device was manufactured in 2006.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.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.No further actions are being taken at this time.We consider this investigation closed.Credit will be issued for the device.

• 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: 9918637
• Report Number: 1020279-2020-01128
• Device Sequence Number: 2764823
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2020

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: 04/02/2020
• Device Model Number: 71430442
• Device Catalogue Number: 71430442
• Device Lot Number: 06FM18680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 07/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1