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

Model Number	71631110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that the drill bit broke during surgery, inside the patient.Surgical delay more than 30 minutes.The procedure finished with a smith and nephew backup device.Patient injuries were not reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation but the picture was reviewed, and the breakage was confirmed.The clinical / medical investigation concluded that, no relevant clinical information has been provided for inclusion in this medical investigation.However, per subsequent e-mail, it was reported all the broken pieces were recovered from inside of the patient.According to the report, the procedure was completed with a back-up device with more than a thirty-minute delay.Since there was no harm alleged to this patient, no further clinical/medical assessment is warranted at this time.A complaint history review found related failures 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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.Without the return of the actual product involved, our investigation could not proceed.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 associated device, used in treatment, was returned and evaluated.The lab analysis concluded that a visual inspection of the returned device confirmed the stated failure mode.The device is fractured along the tip, rendering the device inoperative.The device shows signs of extensive use.The clinical/medical evaluation concluded that this case reports the pilot drill broke inside the patient during use.Per email correspondence, all of the pieces were removed from the patient.The procedure was completed with more than a 30-minute delay, using a backup device.There was no harm to the patient.Therefore, no further clinical assessment is warranted.A review of complaint history did not reveal additional complaints for the listed batch.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 and instructions for use documents revealed this failure mode and potential harm was previously identified.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.

• Brand Name: 4.0MM LONG 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: 11391140
• Report Number: 1020279-2021-01689
• Device Sequence Number: 1283681
• Product Code: HRS
• UDI-Device Identifier: 03596010392503
• UDI-Public: 03596010392503
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K123055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 11/16/2021

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: 71631110
• Device Catalogue Number: 71631110
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 08/11/2021; 11/15/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 08/12/2021; 11/16/2021
• 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 Sex: Unknown