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

Model Number	72202868
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	08/23/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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)
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12465650
• Report Number: 1219602-2021-01965
• Device Sequence Number: 17356823
• Product Code: LXH
• UDI-Device Identifier: 00885554000245
• UDI-Public: 00885554000245
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K834370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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: 72202868
• Device Catalogue Number: 72202868
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 10/13/2021
• 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: Required Intervention