MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM; SCREW, FIXATION, BONE

Model Number 201.774

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional pro-code: hrs.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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 on (b)(6) 2019, the scrub tried on the back table and one (1) cortex screw self-tapping with t8 stardrive recess 18mm became incarcerated in the guide block.Additionally, three(3) cortex screw self-tapping with t8 stardrive recess 12mm, three(3) cortex screw self-tapping with t8 stardrive recess 14mm, three(3) cortex screw self-tapping with t8 stardrive recess 18mm, one (1) cortex screw self-tapping with t8 stardrive recess 22mm, two (2) cortex screw self-tapping with t8 stardrive recess  24mm, one (1) cortex screw self-tapping with t8 stardrive recess 28mm would not fit through the guide block.There was no patient involvement.This complaint involves sixteen (16) devices.This complaint involves 16 devices due to the system limitation, these incidents will be captured under this (b)(4) for (10 devices) and linked (b)(4) for (6 devices).This report if for six (6) devices.This report is 4 of 6 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.The screws were visually inspected.Light surface wear, consistent with use and which would not impact the functionality, was noted.However, no defects were identified on either screw.Functional test was performed via returned mating device.It was confirmed that all the screws and all the mating grooves of guide block were not fitting.The condition was determined to agree with the complaint description as the cortex screw and mating guide are not intended to fit.The variable angle lcp two -column volar distal radius plate 2.4 technique guide and the 2.4mm variable angle lcp distal radius system technique guide were reviewed and it was confirmed that cortex screws are not intended to be placed through the guide block.Therefore dimensional analysis was not performed for this screws.Based on design investigation the original complaint and investigation focused on the surgeon attempting to insert a cortex screw through a guide block for two column plate.This section of the two column plate family that receives the guide block for neutral angle screw placement contains va-lcp holes.These holes do not correlate with the usage of cortex screws.The surgical technique for the us and eu both define the usage of threaded locking head implants with the use of the guide block.The surgeon, in this case, is using a screw/plate combination that is not indicated for this particular combination and therefore the complaint can be categorized as user error.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM
• 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: 8579786
• MDR Text Key: 144141785
• Report Number: 2939274-2019-57848
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982142801
• UDI-Public: (01)10886982142801
• 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: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201.774
• Device Catalogue Number: 201.774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Date Manufacturer Received: 05/24/2019
• Patient Sequence Number: 1