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	04/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a trauma surgery, a 1.8/2.4mm double-ended drill guide (case: (b)(4)) broke off, and the drill broke off inside the 2.0/2.7mm double-ended drill guide (case: (b)(4)).Instruments were inside of the patient.The procedure was able to be completed with the same device.Surgery was delay of less than or equal to 30mins.Patient was not harmed.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.One of the devices drill sleeves was broken, rendering the device inoperative.The broken component was not returned.The device shows signs of extensive use.The clinical/medical evaluation concluded that it has not been communicated if the broken drill guide was retrieved from the patient.Based on the limited information provided the root cause for the reported breakage could not be determined.The double-ended drill guide is an externally communicating device, it is neither manufactured nor intended for implantation.It is also not approved for long term internal tissue exposure and long-term implantation data is not available.The patient impact beyond the reported device breakage/retained foreign body during the procedure could not be definitively determined.Although unlikely, the potential for corrosion and local irritation/migration of the drill fragment could not be ruled out.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.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 likely 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.

• 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: 11730134
• Report Number: 1020279-2021-03521
• Device Sequence Number: 11768807
• Product Code: FZX
• UDI-Device Identifier: 00885556387795
• UDI-Public: 00885556387795
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: 71174930
• Device Catalogue Number: 71174930
• Device Lot Number: 15BTD0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Initial Date Received by Manufacturer: 04/03/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 07/21/2021
• 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: Hospitalization; Other; Required Intervention