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

Model Number	71271440
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cement did not mix in a regular and homogeneous way as usual in the container, doctor did not want to use the product because of the abnormal consistency.A second cement package was opened and mixed in its indicated container, which also has an abnormal consistency.Both turned lumpy and yellow.A third cement was opened with the same lot number that was mixed in a usual way and was used in the patient.The device will not be returned.
Additional Manufacturer Narrative
The devices, used in treatment were not returned for evaluation, reporting event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 transit damage/ a strong mechanical-shock during transportation, breakage technique, and/or instruction of use variance.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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
• MDR Report Key: 9545434
• Report Number: 1020279-2020-00079
• Device Sequence Number: 14038716
• 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,Company Representative
• 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: 12/24/2019
• Supplement Date Received by Manufacturer: 04/16/2020; 01/08/2021; 09/27/2022
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 04/19/2020; 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): Yes
• 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