MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM; SCREW, FIXATION, BONE

Model Number	201.770
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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 an unknown date, some of the 2.4mm cortex screws were not fitting through the plate guides for the two column variable angle distal radius plates.The set was opened and tested the three (3) 2.4mm cortex screws 20mm, two (2) 2.4mm cortex 22mm, and one (1) 2.4mm cortex 24mm.The 2.4mm cortex screws would not fit through the guide block for two-column plate 6 hole head, guide block for two-column plate 7 hole head, nor the guide block for two-column plate narrow 6 hole.The rest of the 2.4mm cortex screws did.The issue was found in sterile processing department (spd).There was no patient involvement.Concomitant devices reported: unknown cortex screws (part# unknown, lot# unknown, quantity# unknown).This complaint involves nine (9) devices.This is 7 of 9 for report (b)(4).
Additional 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.A manufacturing related potential cause was not suspected nor identified, therefore, per franchise complaint product investigation procedure no manufacturing record evaluation is required.Visual inspection: 2.4mm cortex screw slf-tpng with t8 stardrive recess 20mm was received at us cq.Upon visual inspection at cq, it is observed that screw looks good without any physical damage.Device failure/ defect found? no.Dimensional inspection: dimensional inspection of the received screw was performed at cq.The diameter of the screw was intended to be measuring from 2.3mm to 2.45mm and it was measured to be 2.39mm.The length of the screw was intended to be measuring from 20.0mm to 20.70mm and it was measured to be 20.54mm.All the dimensions are within specification as per the drawing.Functional inspection: functional inspection cannot be performed at cq as the screw was received by itself without the guide block reported.The reported screw was not intended to interact with the guide block as per the technique guide.Thus, the complaint is being confirmed.Document/ specification review: the following relevant drawings were reviewed during investigation: 2.4mm diameter cortex screw t8 stardrive, 4mm head no design issues were found which can contribute to this complaint condition.Complaint confirmed? yes.Investigation conclusion: a visual inspection, dimensional inspection, and document/specification review were performed as part of this investigation.The complaint is being confirmed as the screw was not intended to interact with the reported guide block as per the technique guide.Misuse of the device is the potential root cause for the reported problem.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, 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.
Additional Manufacturer Narrative
(b)(4).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.H3, h6: the device was received, the investigation is in progress, 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.

• Brand Name: 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM
• 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: 9244334
• Report Number: 2939274-2019-61777
• Device Sequence Number: 2550579
• Product Code: HWC
• UDI-Device Identifier: 10886982142788
• UDI-Public: (01)10886982142788
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2019

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
• Operator of Device: Health Professional
• Device Model Number: 201.770
• Device Catalogue Number: 201.770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 10/06/2019
• Supplement Date Received by Manufacturer: 10/18/2019; 11/05/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 11/04/2019; 11/25/2019
• Patient Sequence Number: 1