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
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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: 9310359
• Report Number: 1020279-2019-03940
• Device Sequence Number: 2131626
• Product Code: MEH
• UDI-Device Identifier: 03596010460479
• UDI-Public: 03596010460479
• Combination Product (Y/N): N
• PMA/510(K) Number: K990666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 71332530
• Device Catalogue Number: 71332530
• Device Lot Number: 19CM21303
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1