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

Model Number 71362295

Device Problems Break (1069); Defective Device (2588)

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

Event Date 10/08/2021

Event Type  malfunction  

Manufacturer Narrative

The device, intended for use in treatment was returned for evaluation. the visual inspection of the returned device confirms the tip of the ref ball jnt screwdriver shaft broke off.The broken piece was not returned with the device.This instrument exhibits signs of significant use and wear.The current investigation is still on going.A supplemental mdr will be sent with the results of investigation that are still pending.Internal complaint reference number: (b)(4).

Event Description

It was reported that a ref ball jnt screwdriver shaft has an unknown failure.No patient involved.The investigation found that the tip broke off.

Manufacturer Narrative

H3, h6: the device, intended for use in treatment was returned for evaluation.The visual inspection of the returned device confirms the tip of the ref ball jnt screwdriver shaft broke off.The broken piece was not returned with the device.This instrument exhibits signs of significant use and wear.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.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.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• 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: 12751031
• MDR Text Key: 280091629
• Report Number: 1020279-2021-07830
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 03596010454201
• UDI-Public: 03596010454201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2011
• Device Model Number: 71362295
• Device Catalogue Number: 71362295
• Device Lot Number: 01KM00090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2021
• 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: Reuse
• Patient Sequence Number: 1