MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCORD DUAL ENDED HEX DRIVER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71360046

Device Problem Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 10/14/2020

Event Type  Injury  

Event Description

It was reported that during use, outside the patient the screwdriver is stripped.Surgical delay less than 30 minutes.The procedure finished with a competitor device.Patient injuries were not reported.

Manufacturer Narrative

Results of investigation: the device, used in treatment, was returned for evaluation.A visual inspection of the returned accord dual ended hex driver confirmed the stated failure.The hex driving tip is 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.This device exhibits signs of significant use and wear.This device was manufactured in 2017.A medical investigation was conducted and this case reports during use outside of the patient, the screwdriver is stripped.Per complaint description, there was no patient injury, and a delay of less than 30 minutes.The procedure was completed with a competitor device.Since no patient harm is alleged, no further clinical assessment is warranted.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.A review of risk management files found that the reported failure was documented appropriately.This device is a reusable instrument 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.

• Brand Name: ACCORD DUAL ENDED HEX DRIVER
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10814684
• MDR Text Key: 215461786
• Report Number: 1020279-2020-06314
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010611543
• UDI-Public: 03596010611543
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 71360046
• Device Catalogue Number: 71360046
• Device Lot Number: 17FM05052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 11/13/2020
• Supplement Dates FDA Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention