MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII CR DEEP FLX ISR TR S5-6 10; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71433445
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a tka surgery, a genesis ii cruciate retaining deep flexion insert trial size 5-6 10m split in half while being inserted into the baseplate.It remains unknown how this procedure was completed and whether or not it caused a surgical delay.No harm was reported to the patient.
Additional Manufacturer Narrative
The device, used in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is broken and has signs of wear and tear from use.According to clinical/medical investigation, the responses to clinical information requests were not provided, therefore, s&n does not have adequate documentation to fully evaluate the root cause of the reported breakage.Based on the information provided, it is unknown how the procedure was completed or if there was a surgical delay.Since no harm to the patient was reported, no further clinical/medical assessment is warranted at this time.A review of the manufacturing records 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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.A review of risk management files found that the reported failure was documented appropriately.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.

• Brand Name: GII CR DEEP FLX ISR TR S5-6 10
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12275992
• Report Number: 1020279-2021-06152
• Device Sequence Number: 17073421
• Product Code: LXH
• UDI-Device Identifier: 00885556480076
• UDI-Public: 00885556480076
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71433445
• Device Catalogue Number: 71433445
• Device Lot Number: 18EB00513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention