MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF BALL JNT SCREWDRIVER SHAFT

Model Number 71362295

Device Problems Break (1069); Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The associated device was returned and evaluated.The visual inspection of the returned device confirms the screwdriver part of the device broke off.The screwdriver portion was not returned with the device.Also the device is rounded off on one end and there are several nicks on the metal of the device.A review of complaint history based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.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, therefore, based on the alleged failure and the date when the product was manufactured, a further review of the manufacturing records was not deemed necessary.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.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.

Event Description

It was reported that, a ref ball jnt screwdriver shaft is damaged.As this was notice in a field inspection, not patient was involved.Results of investigation have concluded that the screwdriver tip was broken which makes it a reportable event.Also, screwdriver is rounded off on one end and there are several nicks on the metal of the device.

• Brand Name: REF BALL JNT SCREWDRIVER SHAFT
• Type of Device: SCREWDRIVER
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14948728
• MDR Text Key: 302490734
• Report Number: 1020279-2022-03256
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 03596010454201
• UDI-Public: 03596010454201
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2012
• Device Model Number: 71362295
• Device Catalogue Number: 71362295
• Device Lot Number: 02DM03754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2022
• Date Manufacturer Received: 07/01/2022
• 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: Unknown
• Patient Sequence Number: 1