MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T7 HOLDING SLEEVE; GUIDE, SURGICAL, INSTRUMENT

Model Number	71174988
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a im nail, the t-handle snapped in half ((b)(4)), the t7 holding sleeve no longer captures (b)(4), and the screw depth gauge broke (b)(4) inside the patient.The procedure was completed, with a delay of fewer than 30 minutes using a s&n back up device.Patient was not harmed.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the returned holding sleeve confirms the end of the device is damage causing the stated failure.The device exhibits signs of significant wear and use.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 any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument 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.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: T7 HOLDING SLEEVE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11780011
• Report Number: 1020279-2021-03754
• Device Sequence Number: 3138130
• Product Code: FZX
• UDI-Device Identifier: 00885556500699
• UDI-Public: 00885556500699
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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: 71174988
• Device Catalogue Number: 71174988
• Device Lot Number: 18MCT0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/23/2021
• Patient Sequence Number: 1