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

Model Number	71631189
Medical Device Problem Code	Break (1069)
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
H3, h6: the device, used in treatment, was returned for evaluation.The visual inspection confirms the scale portion of the device is bent at the tip.This device shows significant signs of wear/usage.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 a manufacturing abnormality 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.Expected wear/tear is likely the probable cause 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.

• Brand Name: SCREW 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
• MDR Report Key: 11779917
• Report Number: 1020279-2021-03753
• Device Sequence Number: 3138129
• Product Code: KTT
• UDI-Device Identifier: 03596010445681
• UDI-Public: 03596010445681
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K093047
• 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): 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2011
• Device Model Number: 71631189
• Device Catalogue Number: 71631189
• Device Lot Number: 01BM09171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 07/21/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention