MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN COUNT REAM DEPTH STOP; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Model Number	71434451
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon inspection it was noticed that the locking spring was not locking securely of the legion counterbore reamer depth stop.No case involved therefore no patient involved.
Additional Manufacturer Narrative
The associated device, intended for use in treatment, was returned and evaluated.A visual inspection was conducted and confirmed that the lgn count ream depth stop locking spring was not locking properly.The manufactured date for this device is 2013.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 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.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.Should 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.

• Brand Name: LGN COUNT REAM DEPTH STOP
• Common Device Name: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11522615
• Report Number: 1020279-2021-02230
• Device Sequence Number: 19832695
• Product Code: MBH
• UDI-Device Identifier: 03596010549587
• UDI-Public: 03596010549587
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 04/29/2021

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: 71434451
• Device Catalogue Number: 71434451
• Device Lot Number: 13HM11537
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1