MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SHORT DEPTH GAUGE 2.4MM/2.7MM SCREWS; PLATE, FIXATION, BONE

Model Number	71174928
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the depth gauge for 2.4mm and 2.7mm screws was broken.It is unknown if this was noticed during surgery or not; therefore, patient involvement has not been confirmed.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: additional information received by the manufacturer identified that this event should be re-evaluated for mdr reporting.The new information received confirmed that the ruler of a short depth gauge 2.4mm/2.7mm screws broke off.Since the broken part remains outside the patient, the reassessment determined that the issue does not meet the threshold for reporting; therefore, this is a non-reportable event.If further details are provided, our files will be updated accordingly, and a further report submitted outlining both the event details and our investigations performed.
Event or Problem Description
It was reported that the ruler of a short depth gauge 2.4mm/2.7mm screws broke off.It is unknown if this was noticed during surgery or not; therefore, patient involvement has not been confirmed.

• Brand Name: SHORT DEPTH GAUGE 2.4MM/2.7MM SCREWS
• Common Device Name: PLATE, FIXATION, BONE
• 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: 14520257
• Report Number: 1020279-2022-02638
• Device Sequence Number: 20241150
• Product Code: HRS
• UDI-Device Identifier: 00885556399545
• UDI-Public: 00885556399545
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2022
• 2 Devices were Involved in the Event: 1 2

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: 71174928
• Device Catalogue Number: 71174959
• Device Lot Number: 14KTRS122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown