MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT TR S5-6 9; TRAY, SURGICAL, INSTRUMENT

Model Number	71430415
Medical Device Problem Codes	Crack (1135); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the gii ps hi flex isrt tr s5-6 9 is presenting wear and tear.It has chips and cracks.No case related.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The devices, intended for use in treatment, were returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.This device has several nicks, scratches, and gouges rendering the device inoperative.The device shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.These devices are reusable instruments that can be exposed to numerous surgeries; damage from repeated use can occur.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GII PS HI FLEX ISRT TR S5-6 9
• Common Device Name: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11016811
• Report Number: 1020279-2020-07497
• Device Sequence Number: 4562966
• Product Code: FSM
• UDI-Device Identifier: 03596010493057
• UDI-Public: 03596010493057
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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: 71430415
• Device Catalogue Number: 71430415
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1