MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCORD PILOT SCRWDRIVER BIT; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number	71360044
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the accord pilot scrwdriver bit had some issues during total hip replacement procedure the tip end of the screwdriver has broken.It continues to remove some of the threads from the screws and we are not able to tighten it.The procedure was finished using a competitor device.There was a delay greater than 30 minutes reported.
Additional Manufacturer Narrative
H3, h6:the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, without the requested clinical information or the broken tip, a thorough medical investigation cannot be rendered.Per the complaint details, during instrument use outside of the patient the screwdriver tip broke and continued to remove some of the threads from the screws resulting in an inability to tighten it.According to the report, the procedure was finished using a competitor device with a delay greater than 30 minutes reported.Since no additional harm has been 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.This device is a reusable instrument that can be exposed to numerous surgeries.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.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: ACCORD PILOT SCRWDRIVER BIT
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10951588
• Report Number: 1020279-2020-06987
• Device Sequence Number: 3169928
• Product Code: JDG
• UDI-Device Identifier: 03596010568205
• UDI-Public: 3596010568205
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (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): 08/17/2021

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 Catalogue Number: 71360044
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 08/17/2021
• 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: Hospitalization; Required Intervention