MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 1.8MM DRILL SHORT W/AO QC; BIT, DRILL

Model Number	71174905
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during use, there was a quality failure of the 1.8mm drill short w/ao qc of the evos system.It is unknown how the problem was solved or if there was a delay due to this event.No patient complications reported.As per investigation results, it was found that the tip of the device was chipped.
Event or Problem Description
It was reported that, during a left clavicle osteosynthesis, the 1.8mm drill short w/ao qc broke and a fragment was left inside patient.It is unknown how the procedure was completed or if there was a delay due to this event.Patient's health status is unknown.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device confirms the tip on the device is chipped rendering the device inoperative.This device exhibits signs of significant wear/usage.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.The clinical/medical evaluation concluded that the drill short broke and a fragment was left inside the patient.One photo of the returned device was reviewed appears to show a breakage at the tip of the device.The visual inspection report found the tip on the device to be chipped.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.Therefore, the root cause of the reported breakage could not be determined.The material composition of the drill is 17-4 stainless steel.The drill shorts 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.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.This is a single-use device and should be discarded after its first use.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: 1.8MM DRILL SHORT W/AO QC
• Common Device Name: BIT, DRILL
• 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: 14611388
• Report Number: 1020279-2022-02769
• Device Sequence Number: 5115681
• Product Code: HTW
• UDI-Device Identifier: 00885556386545
• UDI-Public: 00885556386545
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2022

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 Expiration Date: 08/03/2025
• Device Model Number: 71174905
• Device Catalogue Number: 71174905
• Device Lot Number: 15BNX0058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 06/08/2022; 07/15/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 06/10/2022; 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2015
• 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 Age: 32 YR
• Patient Sex: Female