MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 45MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number 71332545

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2020

Event Type  Injury  

Event Description

It was reported that, during surgery, doctor drilled a hole thru the r3 3-hole cup and when trying to install the 6.5 x 45 spheric head screw it got stuck and began stripping.He re-drilled into the hole and tried to install the screw but the same thing happened with the same screw.Procedure concluded with a back-up device from smith and nephew.A delay of less than 30 minutes and no injury reported.

Manufacturer Narrative

H6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The threads on the device are heavily damaged / stripped from attempted use.Pieces of the threads were fractured off and were returned.The clinical medical investigation concluded that this complaint from the united states reports that during surgery, the doctor drilled a hole thru the r3 3 hole cup and when trying to install the 6.5 x 45 screw it got stuck and began stripping.He tried again, re-drilled into the hole and tried to install the screw but the same thing happened with the same screw.The procedure was completed with a backup device from smith and nephew.A delay of less than 30 minutes occurred.No patient injury or harm was reported.A dimensional inspection was attempted but the device was too damaged from the attempted insertion to obtain accurate measurements.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: REF SPHER HEAD SCREW 45MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10171478
• MDR Text Key: 195717651
• Report Number: 1020279-2020-02549
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010462695
• UDI-Public: 03596010462695
• Combination Product (y/n): N
• PMA/PMN Number: K090666
• 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: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71332545
• Device Catalogue Number: 71332545
• Device Lot Number: 19CB00512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Date Manufacturer Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention