MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN SUSPENSORY FIXATION DEV; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 03/01/2021

Event Type  Injury  

Event Description

It was reported that on literature review medium-term (least 5 years) comparative outcomes in anterior cruciate ligament reconstruction using 4shg, allograft, and lars ligament, 3 patients had a superficial surgical site infection after an anterior cruciate ligament procedure using an endobutton.Patients were treated with antibiotics after a disturbed period of wound healing.No further information is available.

Manufacturer Narrative

Internal complaint reference (b)(4).

• Brand Name: UNKN SUSPENSORY FIXATION DEV
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16005495
• MDR Text Key: 305716120
• Report Number: 1219602-2022-01999
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K980155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other