MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.0MM DRILL SHORT W/AO QC; BIT, DRILL

Model Number	71174910
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an osteosynthesis of multiple fractures on the distal humerus, the 2.0mm drill short w/ao qc broke off in one of the perforations for placing the screws.It was attempted to remove the broken piece from the bone by using the respective technique with a variable angle drill guide, but it was not possible, so, the surgeon decided to leave the broken piece inside of the patient.The procedure was resumed, after a non-significant delay, using an s+n backup device.No further complications were reported as a consequence of this problem.
Additional Manufacturer Narrative
- please be aware that additional information (d4, h4) was received on 13-apr-2023.- please be aware that b5 was corrected according to the information received on 13-apr-2023.- please be aware that the original aware date (g4) of this event was 02-mar-2023.
Event or Problem Description
It was reported that, during an osteosynthesis for multiple fractures of the distal humerus of a child, the 2.0mm drill short w/ao qc broke off in one of the many perforations for placing the screws.It was attempted to remove the broken piece from the bone by using the respective technique with the use of a variable angle drill guide, but it was not possible, so the surgeon decided to leave it there.The procedure was resumed, after a non-significant delay, using an s+n backup device.No further complications were reported as a consequence of this problem, the patient's health condition is stable.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, as of the date, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.Per case details, ¿the patient¿s health condition is stable.¿ however, it was reported that the drill bit could not be removed from the patient¿s bone.The material composition for the reported device is 17-4 ph stainless steel.The drills are 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 tissue data is not available.The patient impact beyond the reported device breakage and retention of broken pieces could not be determined.However, local irritation, migration, tissue inflammation, and/or pain cannot be ruled out as potential side effects if any portion of the retained device.Additionally, the procedure was completed after a non-significant delay using a smith and nephew backup device.No further medical assessment can be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of instructions for use for care, maintenance, cleaning, and sterilization of smith & nephew orthopedics devices for single-use devices revealed that as the devices are sold both nonsterile and sterile and often removed from their original packaging to be placed in a containment device they should be cleaned and/or inspected prior to sterilization.The device should not be reprocessed or reused if comes in contact with blood, tissue or bodily fluids.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.This is a single use device, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.Based on this investigation, the need for corrective action is not indicated.Should the device or 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.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection revealed the tip broke off.The broken piece was not returned.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.Per case details, ¿the patient¿s health condition is stable.¿ however, it was reported that the drill bit could not be removed from the patient¿s bone.The material composition for the reported device is stainless steel.The drills are 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 tissue data is not available.The patient impact beyond the reported device breakage and retention of broken pieces could not be determined.However, local irritation, migration, tissue inflammation, and/or pain cannot be ruled out as potential side effects if any portion of the retained device.Additionally, the procedure was completed after a non-significant delay using a smith and nephew backup device.No further medical assessment can be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of instructions for care, maintenance, cleaning and sterilization of smith & nephew orthopedics devices for single use devices revealed that as the devices are sold both nonsterile and sterile and often removed from their original packaging to be placed in a containment device they should be cleaned and/or inspected prior to sterilization.The device should not be reprocessed or reused if comes in contact with blood, tissue or bodily fluids.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.This is a single use device, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.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: 2.0MM DRILL SHORT W/AO QC
• Common Device Name: BIT, DRILL
• 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: 16727983
• Report Number: 1020279-2023-00797
• Device Sequence Number: 18134461
• Product Code: HTW
• UDI-Device Identifier: 00885556386798
• UDI-Public: 00885556386798
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/21/2023

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: 71174910
• Device Catalogue Number: 71174910
• Device Lot Number: 21LUQ0065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 03/02/2023; 04/27/2023; 07/20/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/03/2023; 05/04/2023; 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 13 YR
• Patient Sex: Male