MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 1.8/2.4MM DOUBLE-ENDED DRILL GUIDE; GUIDE, SURGICAL, INSTRUMENT

Model Number	71174930
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number case: (b)(4).
Event or Problem Description
It was reported that, during a trauma surgery, a 1.8/2.4mm double-ended drill guide broke inside the patient.All pieces were recovered from the patient.Surgery was resumed, without any delay.Patient was not injured as consequence of this problem.It is unknown how the procedure was completed.
Additional Manufacturer Narrative
G3, h2,h3 and h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device tip has what appears to be a drill bit stuck inside, rendering the device inoperative.The device shows signs of extensive use.The clinical/medical evaluation concluded that per the complaint details, we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.Per subsequent e-mail, it was reported, the breakage of the drill was due to overuse of the instrument.Based on the information provided, all the broken pieces were removed from inside of the patient and surgery was resumed, without any delay, with a smith & nephew back-up device.Since there was no patient injury as consequence of this problem, no further clinical/medical assessment is warranted at this time.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.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are probable causes of the reported event.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.
Event or Problem Description
It was reported that, during a trauma surgery, a 1.8/2.4mm double-ended drill guide broke inside the patient.All pieces were recovered from the patient.Surgery was resumed, without any delay, with a smith & nephew back-up device.Patient was not injured as consequence of this problem.

• Brand Name: 1.8/2.4MM DOUBLE-ENDED DRILL GUIDE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12124862
• Report Number: 1020279-2021-05746
• Device Sequence Number: 3529664
• Product Code: FZX
• UDI-Device Identifier: 00885556387795
• UDI-Public: 00885556387795
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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: 71174930
• Device Catalogue Number: 71174930
• Device Lot Number: 14KTD0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 08/05/2021
• 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