MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT TR S5-6 11; TRAY, SURGICAL, INSTRUMENT

Model Number	71430416
Medical Device Problem Codes	Flaked (1246); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tka, a genesis ii ps hi flex insert tr s5-6 11 was chipped and worn.This was noticed while setting up, before use in patient.Surgery was performed, without any delay, with a back-up device instead.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: the device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.A complaint history review found related failures for the listed batch; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned trial confirms multiple scratches, burrs and deep gouges in the plastic.The visual also confirms a small piece of the device is broken off.The broken piece was not returned.This device show significant signs of wear and use.A review of complaint history revealed similar events for the listed device over the previous 24 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and 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 investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII PS HI FLEX ISRT TR S5-6 11
• Common Device Name: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12132244
• Report Number: 1020279-2021-05800
• Device Sequence Number: 19690081
• Product Code: FSM
• UDI-Device Identifier: 03596010493064
• UDI-Public: 03596010493064
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2022

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: 71430416
• Device Catalogue Number: 71430416
• Device Lot Number: 16GB00353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 09/07/2021; 05/04/2022
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 09/08/2021; 05/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown