MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 12; PLATE, FIXATION, BONE

Model Number 201.762

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that (b)(6) 2022, during a procedure the surgeon broke the head of a 2.4 cortex screw while putting the screw into the tibia.The head was removed and the shaft was retained.Procedure was completed successfully without any surgical delay.No patient consequences.Concomitant device reported: unk - screwdrivers: trauma (part# unknown; lot# unknown; quantity: 1) this report is for one (1) 2.4 cortex screw slf-tpng t8 sd rec 12.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.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 Description

It was reported that (b)(6) 2022, during a procedure the surgeon broke the head of a 2.4 cortex screw while putting the screw into the tibia.The head was removed and the shaft was retained.Procedure was completed successfully without any surgical delay.No patient consequences.Concomitant device reported: unk - screwdrivers: trauma (part# unknown; lot# unknown; quantity: 1) this report is for one (1) 2.4 cortex screw slf-tpng t8 sd rec 12.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.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.

• Brand Name: 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 12
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13403478
• MDR Text Key: 286116799
• Report Number: 2939274-2022-00305
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982142733
• UDI-Public: (01)10886982142733
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201.762
• Device Catalogue Number: 201.762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2022
• Initial Date FDA Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWDRIVERS
• Patient Sex: Male