MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 1.5/2.0MM DOUBLE-ENDED DRILL GUIDE; GUIDE, SURGICAL, INSTRUMENT

Model Number	71174924
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an internal fixation surgery, the bit of a 1.5/2.0mm double-ended drill guide got stuck in the 1.5/2.0mm double-ended drill guide and broke.Incident occurred while the instruments were outside the patient.Surgery was resumed, after a non-significant delay, with a smith and nephew back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The 1.5mm drill guide sleeve was not returned to be able to determine if the drill bits became stuck within it.The device shows signs of extensive use.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.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 future complaints and investigate as necessary.
Event or Problem Description
It was reported that, during an internal fixation surgery, the bit of a 1.5/2.0mm double-ended drill guide got stuck in the 1.5/2.0mm double-ended drill guide and broke.The drill bit broke while drilling inside the patient.One piece was stuck in the drill guide and the other was in the ao connector of the drill.The two pieces were then matched to each other and x-rays were taken to confirm there were no remaining pieces.Surgery was resumed, after a non-significant delay, with a smith and nephew back-up device.Patient was not injured as consequence of this problem.

• Brand Name: 1.5/2.0MM 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: 12408526
• Report Number: 1020279-2021-06676
• Device Sequence Number: 3349934
• Product Code: FZX
• UDI-Device Identifier: 00885556387498
• UDI-Public: 00885556387498
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 09/09/2021

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: 71174924
• Device Catalogue Number: 71174924
• Device Lot Number: 15ATD0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 09/08/2021; 09/08/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 09/09/2021; 09/09/2021
• 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
• Patient Age: 26 YR
• Patient Weight: 96