MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.7MM SHORT DRILL {} BIT W/QC; PLATE, FIXATION, BONE

Model Number	71173502
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a thr procedure, while drilling the 2.7mm short drill {} bit w/qc broke inside the patient.Surgeon decided to leave the piece inside as it was difficult to remove.Surgery was resumed, without any delay, with a smith and nephew back-up device.No further complications reported.
Additional Manufacturer Narrative
H6: health effect - impact code.Section h3, h6: the device was not returned for evaluation.The shipping information was provided and several attempts to locate the device were performed.The tracking number provided shows the device was picked up in china and delivered in germany; shipper was asked if tracking number was correct but no response was received from shipper, therefore this case will be handled as no product return.If the device or new information is received, this complaint will be re-opened.However, the photograph was reviewed, and revealed that the device is broken.The clinical/medical investigation concluded that, this case reports, the short drill bit broke inside the patient during drilling in a total hip replacement surgery.Per case details, the surgeon decided the broken piece was difficult to remove and was not recovered from the patient.The material composition for the drill bit is 17-4 ph stainless steel.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.Therefore, the root cause of the reported short drill bit breakage could not be determined.The short drill bits 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.The patient impact beyond possible micro-motion and/or migration, and local irritation/discomfort cannot be determined.No further medical assessment can be rendered at this time.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 24 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 instructions for use file is not applicable for this instrument.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.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 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
H3, h6: the shipping information was provided and all efforts were made to locate the device, however the subject device was not made available to the designated complaint unit and thus a physical product evaluation could not be performed.However, the photograph was reviewed, and revealed that the device is broken.The clinical/medical investigation concluded that, this case reports, the short drill bit broke inside the patient during drilling in a total hip replacement surgery.Per case details, the surgeon decided the broken piece was difficult to remove and was not recovered from the patient.The material composition for the drill bit is 17-4 ph stainless steel.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.Therefore, the root cause of the reported short drill bit breakage could not be determined.The short drill bits 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.The patient impact beyond possible micro-motion and/or migration, and local irritation/discomfort cannot be determined.No further medical assessment can be rendered at this time.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 24 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 instructions 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 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.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.

• Brand Name: 2.7MM SHORT DRILL {} BIT W/QC
• 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: 14638823
• Report Number: 1020279-2022-02813
• Device Sequence Number: 20059836
• Product Code: HRS
• UDI-Device Identifier: 03596010519702
• UDI-Public: 03596010519702
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2023

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: 71173502
• Device Catalogue Number: 71173502
• 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: 05/22/2022
• Supplement Date Received by Manufacturer: 01/26/2023; 06/08/2023
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 02/01/2023; 06/09/2023
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 52 KG