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
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: hrs.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(6) 2019, the two (2) cortex screws did not hold onto the unknown screwdriver.There was a surgical delay of one (1) minute.Procedure was completed successfully.The patient was not harmed.Concomitant devices reported: unknown - screwdriver: (part # unknown, lot # unknown, quantity 1).This complaint involves one (1) device.This report is 1 of 1 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: a product investigation was completed: the 1.5 mm cortex screw self-tapping with t4 stardrive recess 10 mm (part 02.214.110, lot unknown) was received with minimal signs of wear.The stardrive recess shows signs of being deformed.A functional test could not be performed since the screwdriver was not returned with the returned screws.The complaint was not able to be replicated.However, the complaint is confirmed for deformation to the stardrive recess which would cause issues when trying to pick the screw up with any screwdriver.Dimensional analysis was completed, the inner diameter of the stardrive recess did not meet the specification based on the drawing.The relevant drawing(s) was reviewed.The complaint condition is confirmed as the 1.5 mm cortex screw self-tapping was received with deformation to the stardrive recess.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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
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.H3, h6: the device was received, the investigation is in progress and no conclusion could be drawn at the time of filing this report, as product is entering the complaint system.H11: d10: complainant part is not expected to be returned for manufacturer review/investigation.Device was used for treatment, not diagnosis.
Event or Problem Description
1/28/2019: updated event description it was reported that on (b)(6) 2019, the two (2) cortex screws did not hold onto the unknown screwdriver.There was a surgical delay of one (1) minute.Procedure was completed successfully.The patient was not harmed.Concomitant devices reported: unknown - screwdriver: (part # unknown, lot # unknown, quantity 1).This complaint involves two (2) devices.This report is 1 of 2 for (b)(4).

• Brand Name: 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 10MM
• 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: 8282811
• Report Number: 2939274-2019-56097
• Device Sequence Number: 16172305
• Product Code: HWC
• UDI-Device Identifier: 10886982055446
• UDI-Public: (01)10886982055446
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 01/08/2019

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: 02.214.110
• Device Catalogue Number: 02.214.110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 01/28/2019; 02/21/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 01/29/2019; 02/22/2019
• Patient Sequence Number: 1
• Patient Age: 37 YR