MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM; SCREW,FIXATION,BONE

Model Number 201.768

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 10/04/2019

Event Type  Injury  

Manufacturer Narrative

Additional device procode: hrs.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.(b)(4).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, during on a distal radius surgery, the surgeon attempted to insert a one (1) cortex screw self-tapping with stardrive recess through a , one (1) guide block for two-column plate on, a one (1) variable angle (va) narrow two-column volar distal radius plate.The cortex screw would not fit through the guide block and proceeded to test out two (2) additional cortex screw on the back table through a separate guide block and was unsuccessful, a va locking screw was used instead.There was no surgical delay.The procedure successfully completed.No patient consequence.Concomitant device reported: variable angle (va) narrow two-column volar distal radius plate (part #: 02.111.531 lot #: unknown, quantity #: 1).This is report 2 of 5 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 2.4 mm cortex screw self-tapping with t8 stardrive recess 18 mm (part # 201.768, lot #18p3794, mfg # oct 05, 2019) was received at us cq with no visual defects.Functional test: a functional test could not be performed since the guide block was not returned.The complaint could not be replicated; therefore, the complaint is not confirmed.Dimensional inspection: dimensional analysis was completed, the outer diameter of the screw head measured 4.02 mm (caliper ca818).This is within specification of 3.7 mm to 4.3 mm.Conclusion: based on design investigation pie 1403909 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 history lot manufacturing location: monument, manufacturing date: oct 05, 2019, part number: 201.768, 2.4mm cortex screw slf-tpng with t8 stardrive recess 18mm, lot number: 18p3794 (non-sterile), lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, inspect dimensional / final inspection, ns069465 rev c met all inspection acceptance criteria.Packaging label logs (pll) lppf rev d, lmd rev a were reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 02.211.127.999, 2.8mm sec screw blank 31mm no head turn/no point w/sd8, lot number: 17p3306, lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, header inspect, ns072117 rev b met all inspection acceptance criteria.Device history review nov 26, 2019.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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 18MM
• 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: 9243704
• MDR Text Key: 173907404
• Report Number: 2939274-2019-61679
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982142771
• UDI-Public: (01)10886982142771
• 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
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 201.768
• Device Catalogue Number: 201.768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 11/27/2019
• Supplement Dates FDA Received: 11/28/2019
• Patient Sequence Number: 1
• Treatment: 2.4MMTI VA-LCP2-COL DSTL RADPL NRW6H HD/3HSHAFT/LT
• Patient Outcome(s): Required Intervention