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

Catalog Number	71174988
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during trauma surgery, one (1) t7 holding sleeve broke while putting in screws.The procedure was completed without delay using a s+n back-up device.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.The investigation results concluded that the device was not broken; therefore, it is not a reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly, and a further report submitted outlining both the event details and our investigations performed.H3, h6: the associated device was returned and evaluated.The visual inspection revealed that biological debris clogging the device, the device is undamaged.A functional evaluation performed on the device revealed that the device is unable to actuate due to the presence of biological debris dried to the inner shaft and spring of the device.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.For cleaning procedures please refer to smith and nephew¿s recommended cleaning methods given in our cleaning and sterilization brochure- ¿instructions for care, maintenance, cleaning and sterilization of smith & nephew orthopedic devices¿.The document is available through customer service or via the smith and nephew website, which suggests using a surgical scrub brush to remove visible debris.Factors and/or potential causes that could contribute to the reported event include reprocessing error during cleaning/sterilization.This device is a reusable instrument that can be exposed to numerous surgeries.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: T7 HOLDING SLEEVE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 21291199
• Report Number: 1020279-2025-00207
• Device Sequence Number: 21171154
• Product Code: FZX
• UDI-Device Identifier: 00885556500699
• UDI-Public: 885556500699
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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: 71174988
• Device Lot Number: 20FCT0020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown