MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF CUP POSITIONER/IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71362299

Device Problem Flaked (1246)

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

Event Date 08/08/2022

Event Type  malfunction  

Event Description

It was reported that, during thr surgery, the threads at the distal tip of the ref cup positioner/impactor were sheared not allowing the cup to be screwed on.The procedure was completed using an s+n back-up device.Surgery was less than or equal to 30 mins delayed.The patient was not harmed.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.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 complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, 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.The anticipated risk level is still adequate.A historical review concluded that this event was previously identified.It has been concluded that there is a potential for breakage if used after the expected lifetime or excessive force is used as this device is a reusable instrument and it is expected to wear over time.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.The contribution of the device to the reported event could not be corroborated.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: REF CUP POSITIONER/IMPACTOR
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 15288632
• MDR Text Key: 305252903
• Report Number: 1020279-2022-03829
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010443236
• UDI-Public: 03596010443236
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123598
• 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: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71362299
• Device Catalogue Number: 71362299
• Device Lot Number: 22AK00066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2022
• Date Device Manufactured: 01/20/2022
• 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