MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BLOCK SCREW DEVICE; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71654515
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set up inspection the block screw device got rusted from the small pins and spreads to other part of the device.No delay.Procedure finished with the same device.No injuries.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was returned for evaluation.The clinical/medical task concluded, per complaint details, the findings of the reported, ¿rust¿ occurred during setup.As a result, the surgeon finished the procedure with the same device.Since the reported rust never came in contact with the patient and there was no reported harm or injury to the patient, no further clinical/medical assessment is warranted at this time.Should any additional medical information be provided, this complaint will be re-assessed.A visual inspection confirmed the block screw device shows discoloration.The device shows significant signs of wear/usage.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 have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: BLOCK SCREW DEVICE
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10576945
• Report Number: 1020279-2020-04830
• Device Sequence Number: 16927630
• Product Code: JDG
• UDI-Device Identifier: 03596010585776
• UDI-Public: 03596010585776
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71654515
• Device Catalogue Number: 71654515
• Device Lot Number: 07JM00039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention