MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 90MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.090S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 or Problem Description
It was reported that on (b)(6) 2020, the surgeon was performing a proximal femoral nailing system (tfna) and the screw apparently not raised when inserting the lag screw normally.The nail and the lag screw were damaged, they were trying to figure out why it was not working.There was no surgical delay reported.The procedure was completed with other implants of the same size.There was no adverse event to the patient.This complaint involves two (2) devices.This report is for one (1) tfna screw 90mm - sterile.This report is 2 of 2 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 information: g1: manufacturer site country code.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.H3, h4, h6- 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 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
Concomitant devices reported: 12mm/130 deg ti cann tfna 380mm/left-sterile (part# 04.037.259s, lot# 32p0078, quantity# 1).

• Brand Name: TFNA SCREW 90MM - STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9988062
• Report Number: 2939274-2020-01996
• Device Sequence Number: 19758033
• Product Code: HSB
• UDI-Device Identifier: 10886982098474
• UDI-Public: (01)10886982098474
• Combination Product (Y/N): N
• Initial Reporter State: IL
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2020

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: 04.038.090S
• Device Catalogue Number: 04.038.090S
• Device Lot Number: H0474450
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 05/06/2020; 05/07/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 05/06/2020; 05/08/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 12MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE