MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRAUMA & EXTREMITIES DEV; BIT, DRILL

Model Number 71174934

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2020

Event Type  malfunction  

Event Description

It was reported during the procedure, that the device was broke outside the patient.No pieces fell into the patient.The procedure was completed without delay and with a backup from smith & nephew.No patient injury or other complications were reported.

Manufacturer Narrative

The device, intended for use in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further investigation warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The drill bit has broken off inside the mating tool, rendering the device inoperative.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.As the device broke inside the guide and it cannot longer fit its purpose, the contribution of the device to the reported event could be corroborated.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 future complaints and investigate as necessary.We consider this investigation closed.

Manufacturer Narrative

B5 (event description), d1, d2, d4, d10 (device information).

Event Description

It was reported during the procedure, that a drill bit was broke outside the patient.No pieces fell into the patient.The procedure was completed without delay and backup from smith & nephew was available to finish the surgery.The surgeon did not blame the device, the surgeon was satisfied with the surgical outcome.No patient injury or other complications were reported.

• Brand Name: UNKN TRAUMA & EXTREMITIES DEV
• Type of Device: 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 ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 10787288
• MDR Text Key: 214627881
• Report Number: 1020279-2020-06156
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00885556387993
• UDI-Public: 00885556387993
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71174934
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 05/04/2021; 05/04/2021; 12/16/2022
• Supplement Dates FDA Received: 05/08/2021; 11/21/2022; 12/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: PN: 71174934 / LOT NUM: 17MTD0009