MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FLEXIBLE DRILL 50MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71362950
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drill bit was used in a total hip replacement procedure to drill a hole for reflection screw, after three uses the drill bent.Procedure finished with a smith and nephew backup device.Patient injuries were not reported.Surgical delay less than 30 minutes.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the associated device, intended to use in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.A relationship, if any, between the device and the reported incident could not be corroborated.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: FLEXIBLE DRILL 50MM
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10749542
• Report Number: 1020279-2020-05895
• Device Sequence Number: 14414262
• Product Code: JDG
• UDI-Device Identifier: 03596010463005
• UDI-Public: 03596010463005
• Combination Product (Y/N): N
• Initial Reporter Country: IZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71362950
• Device Catalogue Number: 71362950
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2020
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1