MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM / TI CANN FRN / GT 380MM / LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.033.169S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, during a post-operative computerized tomography (ct) scan for a different injury, a non-displaced femoral neck fracture was discovered.Initially, the patient was implanted with a femoral recon nail system, on an unknown date, due to a subtroch fracture.No corrective surgery was performed.Concomitant devices reported: unknown recon screws (part# unknown, lot# unknown, quantity 2), unknown locking screw (part# unknown, lot# unknown, quantity 1), unknown end cap (part# unknown, lot# unknown, quantity 1), unknown hammet/ mallet (part# unknown, lot# unknown, quantity 1).This report is for 1 11mm / ti cann frn / gt 380mm / left - 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.A2: exact patient age or date of birth are unknown.Patient age reported as mid-to-late twenties.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 noted the original case went without complication.The neck fracture was well fixated with the two (2) recon screws that had been inserted, but the fracture had not been noticed pre-or-intraoperatively.The surgeon also commented that it could have occurred upon insertion of the nail when using the the mallet/hammer.No additional surgery was needed.

• Brand Name: 11MM / TI CANN FRN / GT 380MM / LEFT - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10763481
• Report Number: 2939274-2020-04904
• Device Sequence Number: 3184948
• Product Code: HSB
• UDI-Device Identifier: 10886982271709
• UDI-Public: (01)10886982271709
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.033.169S
• Device Catalogue Number: 04.033.169S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/04/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 11/24/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - END CAPS; UNK - SCREWS: LOCKING; UNK - SCREWS: TRAUMA; UNK - END CAPS; UNK - SCREWS: LOCKING; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention