MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC WASHER 13.0MM; WASHER, BOLT NUT

Model Number	219.99
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).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.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.If additional information is made available, the investigation will be updated as applicable.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 unknown date, the patient underwent a removal hardware procedure from a proximal tibia due to pain.Removal of two (2) 6.5/7.3 cannulated screws and two (2) 13mm washers from a proximal tibia that had healed.The patient requested to have the hardware removed because of pain.The hardware was removed successfully.There was no patient consequence.This report involves one (1) washer 13.0mm.This is report 4 of 4 for (b)(4).

• Brand Name: WASHER 13.0MM
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11701460
• Report Number: 2939274-2021-01998
• Device Sequence Number: 3634475
• Product Code: HTN
• UDI-Device Identifier: 10886982156297
• UDI-Public: (01)10886982156297
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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: 219.99
• Device Catalogue Number: 219.99
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 04/21/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: 6.5 MM AND 7.3 MM CANNULATED; UNK - SCREWS: 6.5 MM AND 7.3 MM CANNULATED; WASHER 13.0MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 92