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

Model Number	71631121
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference number: (b)(4).
Event or Problem Description
It was reported that during surgery, when performing the proximal locking of the nail, the surgeon made a sudden movement when removing the 4.0mm long ao pilot drill from the needle.It was noticed that it had broken and a piece remained inside the patient.The specialist tried to remove the part of the drill bit that remained in the bone, but when he realized that it was not possible in a simple way, decided to leave it inside the patient's bone.The procedure was resumed, after a non-significant delay, with a s+n back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection confirms the 4.0mm long ao pilot drill tip broke off.The broken piece was not returned.The device exhibits signs of significant use and wear.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.The clinical/medical evaluation concluded that based on the information provided, the root cause of the reported drill bit breakage was likely due to an unintentional human error.The 4.0mm long ao pilot drills are comprised of stainless steele, they are manufactured and intended as externally communicating devices and are not approved for long term internal tissue exposure and long-term implantation data is not available.According to the reported the drill bit was retained inside of the patient¿s bone, therefore, micro-motion and/or migration of the retained drill bit is unlikely, even though, we cannot make any conclusions on the impact of the non-implantable foreign body to the patient as we cannot confirm the location of the retained portion of the drill but it was reported the patient was not injured as consequence of this problem.Therefore, the impact to the patient beyond the reported retained drill bit, the non-significant surgical extension and the modified surgical procedure could not be determined.Should any additional relevant medical information be provided, this case would be reassessed.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.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.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.Reuse may increase risk of breakage, failure, patient infection, patient injury and revision surgery.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.We consider this investigation closed.

• Brand Name: 4.0MM LONG AO PILOT DRILL
• Common Device Name: 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: 17102357
• Report Number: 1020279-2023-01271
• Device Sequence Number: 16627309
• Product Code: HRS
• UDI-Device Identifier: 03596010497468
• UDI-Public: 03596010497468
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K123055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2023

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: 71631121
• Device Catalogue Number: 71631121
• Device Lot Number: 22AUQ0042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 06/11/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Male