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

Catalog Number	71360044
Medical Device Problem Codes	Mechanical Problem (1384); Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the accord pilot screwdriver bit are not seating properly, causing screws to feel like they are stripped during trauma fem.Nailing.Incident occurred during surgery with instruments inside the patient.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The devices, used in treatment, were returned for evaluation.A visual inspection of the returned accord dual ended hex drivers confirmed the stated failure.The hex driving tips are rounded and deformed.A hex can strip if the torque applied to the driver exceeds the material strength or if the hex is not seated within the screw when torque is applied.These devices exhibit signs of significant use and wear.These devices were manufactured in 2012.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.These devices are reusable instruments that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause 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.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; 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: 10171820
• Report Number: 1020279-2020-02561
• Device Sequence Number: 19412814
• Product Code: JDG
• UDI-Device Identifier: 03596010568205
• UDI-Public: 3596010568205
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2020

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 Catalogue Number: 71360044
• Device Lot Number: 12LM00785
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1