MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/32MM; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Model Number 02.231.232

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Additional product code hrs hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 Description

It was reported that on (b)(6) 2020, the patient underwent a removal and revision of hardware due to fall.No fragments generated.No surgical delay.The procedure successfully completed.Patient outcome is unknown.This complaint involves eleven (11) devices.This report is for (1) 5.0mm variable angle lockng screw/slf-tpng/strdrv/32mm.This report is 7 of 10 for (b)(4).Related product complaint: (b)(4).

• Brand Name: 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/32MM
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11165106
• MDR Text Key: 226646769
• Report Number: 2939274-2021-00259
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982062086
• UDI-Public: (01)10886982062086
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.231.232
• Device Catalogue Number: 02.231.232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 4.5MM CORTEX SCREW SELF-TAPPING 32MM; 4.5MM CORTEX SCREW SELF-TAPPING 70MM; 4.5MM VA-LCP CRVD CNDYLR PLT/8HLE/195MM/LT-STR; 5.0MM CANNULATED VA LOCKING SCREW/55MM; 5.0MM CANNULATED VA LOCKING SCREW/60MM; 5.0MM CANNULATED VA LOCKING SCREW/60MM; 5.0MM CANNULATED VA LOCKING SCREW/75MM; 5.0MM VRBL ANGL LCKN SCW/SLF-TPNG/STDR/32MM; 5.0MM VRBL ANGL LCKN SCW/SLF-TPNG/STDR/34MM
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR