MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VERSABOND AB 40 GRAMS F2; BONE CEMENT

Model Number	71271440
Medical Device Problem Code	Clumping in Device or Device Ingredient (1095)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the cement did not mix in a regular and homogeneous way as usual in the container, it was not used due to the abnormal consistency (it turned lumpy and yellow).Instead, competitor cement was used to perform the surgery.It is unknown if there were any delays in the surgery.No patient injuries were reported.
Additional Manufacturer Narrative
The device, used in treatment, were not returned for evaluation and the reported event could not be confirmed.A review of the device history records for the listed batch 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 complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.The supplier was made aware of this occurrence.Factors and/or potential probable causes that could contribute to the reported event have been identified as storage and/or instruction of use variance.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: VERSABOND AB 40 GRAMS F2
• Common Device Name: BONE CEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038246
• MDR Report Key: 9580176
• Report Number: 1020279-2020-00218
• Device Sequence Number: 13546734
• Product Code: LOD
• UDI-Device Identifier: 03596010507372
• UDI-Public: 03596010507372
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• PMA/510(K) Number: K022688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/27/2022

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 Expiration Date: 11/22/2021
• Device Model Number: 71271440
• Device Catalogue Number: 71271440
• Device Lot Number: 18LC07540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 04/22/2020; 01/08/2021; 09/27/2022
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 04/24/2020; 01/11/2021; 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0933-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown