MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 6.5/8.0MM DIR MEAS GAUGE; PLATE, FIXATION, BONE

Model Number	71177138
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference number: case(b)(4).
Event or Problem Description
It was reported that during surgery for neck of femur using smith and nephew chs system, the surgical team decided to use the anti-rotation screw treatment with smith and nephew 7.0mm cannulated screw system.Following correct positioning of the 3.2mm x 300mm threaded guide pin, a measurement was taken using the 6.5/8.0mm direct measuring gauge.Registrar read 105mm from end of the guide pin and requested a 7.0mm x 105mm cannulated screw 16mm thread stainless steel to be opened for use.During insertion of the 105mm screw, it was noted that the 105mm screw was approx 10mm too long.A 7.0mm x 95mm cannulated screw 16mm thread was then requested and inserted over the guide pin.The 95mm screw was noted to be of the correct length.Finally, the chs implantation was then completed with a surgical delay of less than 30 minutes and no injury to the patient.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device does not confirm the stated failure mode.The device shows signs of extensive use.The clinical/medical evaluation concluded that this case reports that the cannulated screw system was used during the surgical procedure.The direct measuring gauge was used to measure the length of screw needed.During insertion, the screw was noted to be approximately 10mm too long.A second screw which was 10mm shorter was then used and noted to be the correct length.The procedure was completed with a minimal surgical delay and no injury to the patient.Therefore, no further clinical assessment is warranted at this time.The graduations of the gauge were deemed within tolerance.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance.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.

• Brand Name: 6.5/8.0MM DIR MEAS GAUGE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11444223
• Report Number: 1020279-2021-01909
• Device Sequence Number: 11781210
• Product Code: HRS
• UDI-Device Identifier: 03596010601551
• UDI-Public: 03596010601551
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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 Model Number: 71177138
• Device Catalogue Number: 71177138
• Device Lot Number: 08FM02084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention