MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STERILE 6.4MM DRILL; PLATE, FIXATION, BONE

Model Number	71631035
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during an internal fixation surgery, the drill bit sterile 6.4mm drill broke.The physician felt the drill bit broke without any previous resistance.Also, attempted to retrieve the drill bit tip, but was not possible.Since the nail had very stable fixation decided to take advantage of it and leave it as is.Surgery was resumed, with a greater 60 minutes delay, with the same device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the broken device was confirmed.The clinical/medical investigation concluded that, the provided undated, unlabeled x-ray supports the complaint and shows a femoral nail with a single lag screw and reduced fracture along with the reported drill bit contained within the femoral neck, however, the root cause of the reported breakage could not be determined.Although we are unable to rule out a procedural variance as a contributory factor.The broken drill tip is comprised of 17.4ss and it is not approved for implantation.According to the surgeon, the broken tip was retained in the nail where the screw should have been, and it was very stable.Therefore, the potential for micro-motion and/or migration of the retained drill bit is unlikely.Based on the information provided, the surgeon resumed the procedure with a 60-minute delay using the same device.Since it was reported the patient was stable and recovering, 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.This is a single use device, 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 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.

• Brand Name: STERILE 6.4MM 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: 12624239
• Report Number: 1020279-2021-07553
• Device Sequence Number: 8443856
• Product Code: HRS
• UDI-Device Identifier: 03596010605962
• UDI-Public: 03596010605962
• Combination Product (Y/N): N
• Initial Reporter Country: JM
• PMA/510(K) Number: K123055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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: 71631035
• Device Catalogue Number: 71631035
• 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: 09/30/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown