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

Catalog Number	71173400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use the device broke where the screws go in due to being over tightened.No pieces fell into the patient's wound or incision.The procedure was completed with the same device.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.Our assessment confirmed the tgr 4.5mm df handle left is broken on the tip.The device shows significant signs of wear/usage.The device was manufactured in 2005.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Documentation review not performed for this event, as no manufacturing, packaging or labeling defects were associated with the reported failure.We recommend that all re-usable instruments be routinely inspected for wear/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.

• Brand Name: TGR 4.5MM DF HANDLE LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8493438
• Report Number: 1020279-2019-01456
• Device Sequence Number: 19245308
• Product Code: HRS
• UDI-Device Identifier: 03596010538512
• UDI-Public: 03596010538512
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

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 Catalogue Number: 71173400
• Device Lot Number: 05EM07516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1