MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 28MM; PLATE,FIXATION,BONE

Model Number	204.828
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: hwc.(b)(4).Investigation summary: 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 during an unknown surgery on (b)(6) 2019, a cortex screw broke.The screw appeared very bent in the final x-rays after implantation.The surgeon decided to remove it and the screw broke upon removal.The surgeon had to make a cortical window in the tibia to get the screw out.All the fragments were removed.The broken screw was replaced with another cortex screw.The surgery was completed with a surgical delay of 20 minutes.Patient outcome is unknown.Concomitant device reported: unknown plate (part# unknown, lot# unknown, quantity# 1).This is report 1 for 1 (b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 28MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9156431
• Report Number: 2939274-2019-61193
• Device Sequence Number: 16672462
• Product Code: HRS
• UDI-Device Identifier: 10886982146328
• UDI-Public: (01)10886982146328
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K131186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2019

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: 204.828
• Device Catalogue Number: 204.828
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 10/04/2019
• 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