MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 110MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.110S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event date is unknown date in 2018.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.A review of the device history records has been requested.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) 2018, the patient underwent a revision surgery of a lag screw and a titanium cannulated trochanteric femoral nailing advanced (tfna) short nail.It was a 110 mm screw that collapsed laterally.Patient reported issues of pain and irritation at the side of the hip and tissue area.The screw was removed, and the shorter 90 mm screw was put in place.After the surgery, the surgeon viewed the x-ray from the original surgery and reported he statically locked the lag screw on the original surgery to prevent guided collapse due to the reverse oblique fracture pattern.The tfna and screw was originally implanted on (b)(6) 2018.There was no delay in the revision surgery.Procedure was successfully completed.Patient outcome was successful.Concomitant device reported: titanium cannulated tfna (part# 04.037.142s, lot# h171125, quantity 1).This report is for one (1) tfna screw 110mm - sterile.This is report 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.Additional narrative: device history lot part number: 04.038.110s.Lot number: 7920235.Part manufacturing date: 09 march 2015.Manufacturing site: elmira.Part expiration date: 31 january 2025.Nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot 7920235 of tfna screws was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lot 7818863 met all specifications with no issues documented that would contribute to this complaint condition.A review of the device history record revealed no complaint related anomalies.This lot met all dimensional and visual criteria at the time of manufacture 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: TFNA SCREW 110MM - 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: 8171065
• Report Number: 2939274-2018-55424
• Device Sequence Number: 1326515
• Product Code: HSB
• UDI-Device Identifier: 10886982098559
• UDI-Public: (01)10886982098559
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: 04.038.110S
• Device Catalogue Number: 04.038.110S
• Device Lot Number: 7920235
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 01/15/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE EVENT DESCRIPTION.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 54