MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TGR 4.5MM DF HANDLE LEFT; PLATE, FIXATION, BONE

Model Number	71173400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device is broken, rendering the device inoperable.The device was manufactured in 2005 and shows signs of extensive use.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.
Event or Problem Description
It was reported that the targeter 4.5mm df handle left it is broken.No further information was provided.It is unknown if there was a case involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: TGR 4.5MM DF HANDLE LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11226451
• Report Number: 1020279-2021-00565
• Device Sequence Number: 3805739
• Product Code: HRS
• UDI-Device Identifier: 03596010538512
• UDI-Public: 03596010538512
• Combination Product (Y/N): N
• PMA/510(K) Number: K123055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/25/2021

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 Expiration Date: 09/06/2015
• Device Model Number: 71173400
• Device Catalogue Number: 71173400
• Device Lot Number: 05HM14179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1