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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during an osteosynthesis, before implanting the nail, the 4.0 mm short ao pilot drill hit a screw and got tangled up in a compress and broke.The broken part was removed with pliers.The procedure was resumed, without any delay, using a s+n back-up device.Patient's health condition is stable.

Manufacturer Narrative

The device was not returned for evaluation but the pictures were reviewed, and revealed that the drill broke in half.The clinical/medical investigation concluded that the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.Based on the information provided, the broken 4.0mm short ao pilot drill broken part was removed with pliers and the surgeon was able to complete the surgery without any delay, using a s+n back-up device.Since there was no damage caused and the patient's health condition is stable, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case 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.Due to the need for a backup device, the contribution of the device to the reported event could be corroborated.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

G4 was corrected.

Manufacturer Narrative

H6: health effect - impact code section h3, h6: the associated device was returned and evaluated.The visual inspection revealed the tip broke off.The broken piece was returned.The device shows signs of significant wear and use.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 contributed to the event.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.Based on the information provided, the broken 4.0mm short ao pilot drill broken part was removed with pliers and the surgeon was able to complete the surgery without any delay, using a s+n back-up device.Since there was no damage caused and the patient's health condition is stable, no further clinical/medical assessment is warranted 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.With the results of this investigation the root cause of this event could not be determined.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.D4: lot # and expiration date.H4: device manufacture date.

• 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: 15612566
• MDR Text Key: 301817939
• Report Number: 1020279-2022-04435
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/08/2023

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
• Device Operator: Health Professional
• Device Model Number: 71631123
• Device Catalogue Number: 71631123
• Device Lot Number: 18HNG0028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/15/2022
• Supplement Dates Manufacturer Received: 11/25/2022; 11/25/2022; 03/07/2023
• Supplement Dates FDA Received: 12/01/2022; 12/01/2022; 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2019
• 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
• Patient Age: 25 YR
• Patient Sex: Female