MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MENISCAL STITCHER STR REPL (PKG 1); ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 72202868

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 08/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Hrishikesh pande, prashant pratim padhi, m.Bhattacharya, functional outcome of arthroscopic repair of bucket handle and longitudinal medial meniscal tears in a military population by inside out and outside in technique: a prospective observational study., journal of arthroscopy and joint surgery, volume 7, issue 3, 2020,pages 137-144,issn 2214-9635, doi:10.1016/j.Jajs.2020.07.003.

Event Description

It was reported that on literature review "functional outcome of arthroscopic repair of bucket handle and longitudinal medial meniscal tears in a military population by inside out and outside in technique: a prospective observational study", after using a meniscal stitcher set smith&nephew device, 4 patients experienced superficial surgical site infection, it was treated with antibiotics.No further information is available.

Manufacturer Narrative

H3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Insufficient product identification information was provided, and thus, a manufacturing record review could not be conducted.A complaint history review concluded this was an isolated event.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: MENISCAL STITCHER STR REPL (PKG 1)
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12465650
• MDR Text Key: 271256242
• Report Number: 1219602-2021-01965
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00885554000245
• UDI-Public: 00885554000245
• Combination Product (y/n): N
• PMA/PMN Number: K834370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72202868
• Device Catalogue Number: 72202868
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention