MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 30MM; PROSTHSIS, HIP, SMI-CONSTRAIND, UNCMNTD, MTL/PLYMR, NN-PRS, CALICUM-PHSPHT

Model Number 71332530

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2019

Event Type  malfunction  

Event Description

It was reported that it appears that a 30mm acetabular screw went through the r3 cup during insertion.This was not noticed until post op x-ray was taken.

Manufacturer Narrative

The devices, used in treatment, were not returned for evaluation; the reported event could not be confirmed.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed parts revealed no prior complaints for the listed batches/failure mode.The potential probable cause of this event is likely an improper surgical technique.

• Brand Name: REF SPHER HEAD SCREW 30MM
• Type of Device: PROSTHSIS, HIP, SMI-CONSTRAIND, UNCMNTD, MTL/PLYMR, NN-PRS, CALICUM-PHSPHT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9310405
• MDR Text Key: 166043936
• Report Number: 1020279-2019-03941
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010460479
• UDI-Public: 03596010460479
• Combination Product (y/n): N
• PMA/PMN Number: K990666
• 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: 04/17/2020

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
• Device Operator: Health Professional
• Device Model Number: 71332530
• Device Catalogue Number: 71332530
• Device Lot Number: 19FB01138
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 04/03/2020
• Supplement Dates FDA Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1