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 Codes	Foreign Body In Patient (2687); 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.Surgical delay more than 30 minutes.Unknown how the procedure finished.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
Information corrected (serious injury event).
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.
Additional Manufacturer Narrative
H3, h6: 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, 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 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.

• 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
• MDR Report Key: 11391141
• Report Number: 1020279-2021-01690
• Device Sequence Number: 11083542
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2021

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
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 02/04/2021; 08/09/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 03/08/2021; 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention