MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN TIBIAL CUTTING BLOCK RIGHT; PROSTHESIS, KNEE, FMOROTIBIAL, SEMI-CONSTRAINED, CMNTD, METAL/POLYMR

Model Number	71434332
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the pin of a right legion tibial cutting block got stuck in a plus 2mm hole and broke off.All pieces recovered from the patient.No harm to the patient or staff.No substantial procedural delay because s&n back up was available.No letter is required.The broken device is being returned to smith & nephew for replacement via fed ex on (b)(6) 2020.(tracking #7778-0586-7360).
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirms a piece of a pin is stuck in the device and cannot be removed.There is no part or lot number for the pin stuck in the device.This device exhibits signs of significant wear/usage.This device was manufactured in 2017.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause 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.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LGN TIBIAL CUTTING BLOCK RIGHT
• Common Device Name: PROSTHESIS, KNEE, FMOROTIBIAL, SEMI-CONSTRAINED, CMNTD, METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9788488
• Report Number: 1020279-2020-00782
• Device Sequence Number: 2778270
• Product Code: HRY
• UDI-Device Identifier: 03596010549822
• UDI-Public: 03596010549822
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• 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): 06/01/2020

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 Model Number: 71434332
• Device Catalogue Number: 71434332
• Device Lot Number: 17MM07950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1