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

Model Number	71631121
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during intramedullary nail procedure, once the nail is implanted inside the femur, it was not possible to fit the long ao pilot drill bits into the nail.The drill was drilled into the bone one last time and when the drill was removed we noticed that it was broken, leaving a part inside the patient's bone.Procedure was completed, after a non-significant delay, by place the conventional nail lock (trochanteric) with a back-up device.Patient's health condition is stable.
Additional Manufacturer Narrative
Section h3, h6: the device was not returned for evaluation but the picture was reviewed and it confirms that the device is broken at the tip.The clinical/medical investigation concluded that, this case reports a tip breakage of the long ao pilot drill, and the broken part was not recovered from the patient.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.The provided undated, unlabeled image supports the complaint.However, the attached intake form was reviewed and it does not aide in determining the root cause.Therefore, the root cause of the reported drill tip breakage could not be determined.The long ao pilot drill tips are comprised of 17.4 ss, and 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.Reportedly, the broken drill is retained in the patient¿s bone, therefore, micro-motion/migration is unlikely.However, we cannot make conclusions on the impact of the non-implantable foreign body.Procedure was completed, after a non-significant delay, by place the conventional nail lock (trochanteric) with a back-up device.Since it was reported the patient's health condition is stable, no further clinical/medical assessment is warranted at this time.A review of the manufacturing records 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 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, damage from misuse, excessive cleaning or rough handling are likely probable causes of the reported event.The contribution of the device to the reported event could be corroborated since the device was broken and a backup device was needed because the drill was no longer fit for use 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
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 this case reports a tip breakage of the long ao pilot drill, and the broken part was not recovered from the patient.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.The provided undated, unlabeled image supports the complaint.However, the attached intake form was reviewed and it does not aide in determining the root cause.Therefore, the root cause of the reported drill tip breakage could not be determined.The long ao pilot drill tips are comprised of 17.4 ss, and 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.Reportedly, the broken drill is retained in the patient¿s bone, therefore, micro-motion/migration is unlikely.However, we cannot make conclusions on the impact of the non-implantable foreign body.Procedure was completed, after a non-significant delay, by place the conventional nail lock (trochanteric) with a back-up device.Since it was reported the patient's health condition is stable, no further clinical/medical assessment is warranted at this time.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.As the device broke and it can no longer fit its purpose, the contribution of the device to the reported event could be corroborated.This is a single use device, damage from misuse, excessive cleaning or rough handling are likely probable causes of 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 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: 13734126
• Report Number: 1020279-2022-01129
• Device Sequence Number: 4544535
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/25/2022

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: 20LSZ0141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 04/08/2022; 08/23/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 04/12/2022; 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 70 KG