MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 38MM; SCREW, FIXATION, BONE

Model Number	204.838
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes 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.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 (b)(6) 2021, during a procedure, a cortical screw broke off in the patient.The cortical screw was used for compression in the plate.The thread of the screw is still in the patient the surgeon concern about taking it out.It is unknown if there was a surgical delay.Procedure outcome and patient status are unknown.This report involves one (1) 3.5mm cortex screw self-tapping 38mm.This is report 1 of 1 for (b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 38MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12447431
• Report Number: 2939274-2021-05254
• Device Sequence Number: 11737914
• Product Code: HWC
• UDI-Device Identifier: 10886982146373
• UDI-Public: (01)10886982146373
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 204.838
• Device Catalogue Number: 204.838
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 09/09/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - PLATES: LCP
• Outcome Attributed to Adverse Event: Required Intervention