MAUDE Adverse Event Report: SMITH & NEPHEW, INC. XTENDOBUTTON ROUND MD17 DIA 7.5 PEG; RETENTION DEVICE, SUTURE

Model Number	71935602
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2020 the patient had a medical intervention (arthroscopic debriment) due to re-rupture of graft.The outcome of the patient is still recovering.No devices were removed during the procedure.No other complications or delay reported.
Additional Manufacturer Narrative
H3, h6: given the nature of the allegation, the device, used in treatment, could not be returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the finite data provided in the crfs (may) support the complaint; however, the limited information is insufficient to base an assessment of the root cause and patient impact beyond the reported events.A review of the case report forms did not provide any insight into the root cause of the reported issue.Although requested, images and surgical reports were not provided.Per the crf the patient is recovering.Should clinical documentation become available in the future, a thorough medical assessment may be rendered at that time.No further medical assessment is warranted at this time.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury and/or patient condition.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 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: XTENDOBUTTON ROUND MD17 DIA 7.5 PEG
• Common Device Name: RETENTION DEVICE, SUTURE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10574810
• Report Number: 1020279-2020-04822
• Device Sequence Number: 17602555
• Product Code: KGS
• UDI-Device Identifier: 00885556702703
• UDI-Public: 00885556702703
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71935602
• Device Catalogue Number: 71935602
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 11/10/2020; 08/11/2021
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 11/10/2020; 08/12/2021
• 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: Hospitalization; Required Intervention
• Patient Weight: 72