MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.0MM SHORT AO PILOT DRILL; PLATE, FIXATION, BONE

Model Number 71631123

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/05/2022

Event Type  Injury  

Event Description

It was reported that, during an osteosynthesis of the tibia, when drilling the hole for the nail locking screw, the 4.0mm short ao pilot drill broke inside the patient's bone.The piece was left inside the patient, x-ray attached.It is unknown how this adverse event was solved.The current health status of the patient is unknown.

Manufacturer Narrative

Internal reference: (b)(4).

Manufacturer Narrative

The device was not returned for evaluation but the picture was reviewed, and revealed that the device is broken.The clinical/medical investigation concluded that, per case details, the short ao pilot drill broke while drilling in the patient¿s bone during an osteosynthesis of the tibia.The broken piece remains inside of the patient¿s bone.The undated photo and x-ray were reviewed and confirm the reported events.However, as of the date of this medical investigation, no additional clinical documentation has been provided.Therefore, there were no clinical factors found which would have contributed to the breakage.The short ao pilot drill is an external communicating device composed of 17-4 ph stainless steel and should have limited tissue/bone contact.However, since the broken piece remains in the patient¿s tibial bone, the potential for micro-motion and/or migration could not be ruled out.No further clinical assessment can be rendered at this time.Should any additional relevant clinical information be provided, this complaint would be re-assessed.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 based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.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 product 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.The contribution of the device to the reported event could be corroborated as the device broke and was left inside the patient.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.

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 device shows signs of significant wear and use.The clinical/medical investigation concluded that, per case details, the short ao pilot drill broke while drilling in the patient¿s bone during an osteosynthesis of the tibia.The broken piece remains inside of the patient¿s bone.The undated photo and x-ray were reviewed and confirm the reported events.However, as of the date of this medical investigation, no additional clinical documentation has been provided.Therefore, there were no clinical factors found which would have contributed to the breakage.The short ao pilot drill is an external communicating device composed of 17-4 ph stainless steel and should have limited tissue/bone contact.However, since the broken piece remains in the patient¿s tibial bone, the potential for micro-motion and/or migration could not be ruled out.No further clinical assessment can be rendered at this time.Should any additional relevant clinical information be provided, this complaint would be re-assessed.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 based on the historical data revealed similar events for the listed batch, 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: 4.0MM SHORT AO PILOT DRILL
• Type of Device: PLATE, FIXATION, BONE
• 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: 15705542
• MDR Text Key: 302763597
• Report Number: 1020279-2022-04619
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 03596010497475
• UDI-Public: 03596010497475
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K123055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71631123
• Device Catalogue Number: 71631123
• Device Lot Number: 18BNG0021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 22 YR
• Patient Sex: Male