MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN COMP SCREW STARTER DRILL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71631448
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).
Event or Problem Description
It was reported that, during a trauma surgery, the tip of a meta-tan comp screw starter drill broke while in use inside the patient.The piece was left in the patient, consultants decision as they could not get it out.The procedure was completed, after a non-significant delay, with the same reported device.It is unknown how this issue is being addressed.Patient's current health status is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Additional information: b5, h6.
Event or Problem Description
It was reported that, during a trauma surgery, the tip of a meta-tan comp screw starter drill broke while in use inside the patient.The piece was left in the patient, consultants decision as they could not get it out.The procedure was completed, after a non-significant delay, with the same reported device.Patient is well and recovering.No revision has been planned, the surgeon feels that this is not the right course of action at the current time.
Additional Manufacturer Narrative
Section h10: the device was not returned for evaluation.Fluoroscopic photos were provided, and shows the drill tip inside of the femur distally to the nail which supports the complaint.The clinical/medical investigation concluded that, based on the information provided, a procedural variance vs user error cannot be ruled out as the likely cause of the reported failure.The retained meta-tan comp screw starter drill tip 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.Consequently, since the drill was retained in the patient¿s bone micro-motion and migration of the retained drill tip is unlikely.However, we cannot make conclusions on the impact of the non-implantable foreign body to the patient.It was reported the procedure was completed, after a non-significant delay, with the same reported device.According to the report, no revision has been planned, the surgeon feels that this is not the right course of action at the current time.Since it was reported the patient is well and recovering, no further clinical/medical assessment is warranted at this time.A review of complaint history of the previous 12 months revealed similar events for the listed device, 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 device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.As the device broke and a piece of it could not be removed from the patient, the contribution of the device 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.Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
Section d4, d9 and h4 were updated.Section h10: the associated device was returned and evaluated.A visual inspection of the returned device reveals the tip broke off.The broken piece was not returned.The device shows signs of significant wear and use.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, a procedural variance vs user error cannot be ruled out as the likely cause of the reported failure.The retained meta-tan comp screw starter drill tip 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.Consequently, since the drill was retained in the patient¿s bone micro-motion and migration of the retained drill tip is unlikely.However, we cannot make conclusions on the impact of the non-implantable foreign body to the patient.It was reported the procedure was completed, after a non-significant delay, with the same reported device.According to the report, no revision has been planned, the surgeon feels that this is not the right course of action at the current time.Since it was reported the patient is well and recovering, 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 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 revealed that visually inspecting for damage or wear, including components in their disassembled state prior to re-assembly as well as ensuring components are re-assembled securely is indicated.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to 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.Internal complaint reference number: (b)(4).

• Brand Name: META-TAN COMP SCREW STARTER DRILL
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 15838240
• Report Number: 1020279-2022-04802
• Device Sequence Number: 5775338
• Product Code: HSB
• UDI-Device Identifier: 00885556158319
• UDI-Public: 00885556158319
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/27/2023

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: 71631448
• Device Catalogue Number: 71631448
• Device Lot Number: 16ENG0162
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 11/21/2022; 12/14/2022; 02/23/2023
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 11/22/2022; 12/21/2022; 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2019
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown