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	09/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an intertan femoral nailing, the tip of a 4.0mm long ao pilot drill broke, and it could not be removed from patient's bone.The procedure was completed with a non-significant delay, using a smith and nephew back up device.Patient status is unknown.
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.The clinical/medical evaluation concluded that smith and nephew has not received relevant clinical information to perform a thorough medical investigation.Based on the information provided, the tip of a 4.0mm long ao pilot drill broke, and it could not be removed from the patient's bone.The retained tip of a 4.0mm long ao pilot drill is comprised of 17.4 ph ss and was 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.However, since the tip was reported as retained inside of the patient¿s bone, micro-motion and/ or migration of the retained tip is unlikely.According to the report, the procedure was completed with a non-significant delay, using a smith and nephew back up device.Since the patient¿s status is unknown, the impact to the patient beyond that which has already reported cannot be determined.Should any additional relevant medical information be provided, this complaint would be re-assessed.A review of complaint history did not reveal similar events for the listed device.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.The manufacturing process of the device did not contribute to the reported event.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.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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.
Additional Manufacturer Narrative
Updated results of investigation: 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.The clinical/medical evaluation concluded that smith and nephew has not received relevant clinical information to perform a thorough medical investigation.Based on the information provided, the tip of a 4.0mm long ao pilot drill broke, and it could not be removed from the patient's bone.The retained tip of a 4.0mm long ao pilot drill is comprised of 17.4 ph ss and was 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.However, since the tip was reported as retained inside of the patient¿s bone, micro-motion and/ or migration of the retained tip is unlikely.According to the report, the procedure was completed with a non-significant delay, using a smith and nephew back up device.Since the patient¿s status is unknown, the impact to the patient beyond that which has already reported cannot be determined.Should any additional relevant medical information be provided, this complaint would be re-assessed.A review of complaint history for the part number over the past 12 months did not reveal similar events for the listed device.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 contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.Damage from misuse 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.
Additional Manufacturer Narrative
Date received by manufacturer.

• 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: 12828490
• Report Number: 1020279-2021-08205
• Device Sequence Number: 7790229
• Product Code: HRS
• UDI-Device Identifier: 03596010497468
• UDI-Public: 03596010497468
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/04/2022

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: 21FUQ0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 01/28/2022; 02/24/2022; 03/04/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 02/01/2022; 03/01/2022; 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown