MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW 26MM; SCREW, FIXATION, BONE

Model Number	204.026
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2021, the patient reports with pain, effusion, drainage, and an inadvertent arthrotomy of the left knee status post it band release and tibial insert revision.Physician confirms a recurrent superficial wound dehiscence of the surgical site with drainage on the lateral aspect due to thinned skin secondary to the it band debulking.The joint capsule arthrotomy is bulging but is intact.The fluid accumulation after physical therapy is causing the surgical site to break open to drain.Patient is put on restrictive movement, given a compressive bandage, steri strips, and prophylactic oral antibiotics.On (b)(6) 2022 the wound dehiscence is healed with a slight bulge.The site is clean and dry with no sign of infection, erythema, or swelling.This report involves one (1) 3.5mm cortex screw 26mm.This is report 1 of 2 for (b)(4).This product complaint, (b)(4), is related to (b)(4) and (b)(4).(b)(4) captures the surgical it band release and (b)(4) captures the revision of tibial insert.

• Brand Name: 3.5MM CORTEX SCREW 26MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13742087
• Report Number: 2939274-2022-00852
• Device Sequence Number: 19963854
• Product Code: HWC
• UDI-Device Identifier: 10886982145413
• UDI-Public: (01)10886982145413
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 204.026
• Device Catalogue Number: 204.026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 03/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.0 CANCELLOUS SCREW PARTIALLY THRD/26
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male