MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 DEPTH GAUGE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	71364451
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal reference number: (b)(4).H3,h6: 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 investigative findings or 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 a thr surgery, the r3 depth gauge broke in half when trying to measure screw length through the cup.It is unknown how the surgery was completed or if this caused a surgical delay.No injuries were reported.
Event or Problem Description
It was reported that, during a thr surgery, the r3 depth gauge broke in half when trying to measure screw length through the cup.All pieces were removed and accounted using a forceps.It is unknown how the surgery was completed or if this caused a surgical delay.No injuries were reported.
Additional Manufacturer Narrative
B5, h6 have been updated.
Additional Manufacturer Narrative
B5, h3 have been updated.Internal reference number: (b)(4).
Event or Problem Description
It was reported that, during a thr surgery, the r3 depth gauge broke in half when trying to measure screw length through the cup.All pieces were removed and accounted using a forceps.The surgery was completed, after a non-significant delay, using a sn back-up device.Patient was not harmed as consequence of this problem.

• Brand Name: R3 DEPTH GAUGE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22084619
• Report Number: 1020279-2025-00949
• Device Sequence Number: 6906915
• Product Code: KTT
• UDI-Device Identifier: 03596010599438
• UDI-Public: 3596010599438
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K093047
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2025

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: 71364451
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 06/10/2025; Not provided
• Initial Report FDA Received Date: 05/26/2025
• Supplement Report FDA Received Date: 06/25/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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