MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 10MM; SCREW, FIXATION, BONE

Model Number 02.214.110

Device Problem Naturally Worn (2988)

Patient Problem Not Applicable (3189)

Event Date 12/28/2018

Event Type  malfunction  

Manufacturer Narrative

Additional product code: hrs.Without a lot number the device history records review could not be completed.Product was not returned.Investigation summary - product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot, device history batch, device history review null.Device was used for treatment, not diagnosis.

Event Description

It was reported that on (b)(6) 2018, the tip of the stardrive screwdriver shaft had twisted and did not fit properly into the head of the cortex.While the surgeon was putting the screw through the plate, the head of the screw was stripped but was inserted successfully into the plate.The plate had no malfunction.There was a surgical delay of ten (10) minutes due to an attempt to remove the screw.It was noted that the stripped screw still provided adequate fixation for this procedure but may be difficult to remove in the event that the hardware should ever need to be removed.Procedure was successfully completed.Patient status is unknown.Concomitant device reported: unknown plate (part # unknown, lot # unknown, quantity # 1).This complaint involved two (2) devices.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.

• Brand Name: 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 10MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8261909
• MDR Text Key: 133852399
• Report Number: 2939274-2019-55947
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982055446
• UDI-Public: (01)10886982055446
• Combination Product (y/n): N
• PMA/PMN Number: K112583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.214.110
• Device Catalogue Number: 02.214.110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2018
• Patient Sequence Number: 1
• Patient Age: 18 YR