MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM / TI CANN FRN / GT 380MM / RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.033.068S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).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 (b)(6) 2020 the patient underwent a revision surgery due to re-fracture of the femur and breakage of the femoral recon nail (frn).Originally, the patient had an implantation on an unknown date.However, on (b)(6) 2019, when the patient was using a walker to maneuver in patient's home, the patient heard a snapping sound and fell into the floor.Thus, a hardware removal was done and an open reduction internal fixation (orif) was performed with a long distal femur locking plate.Patient status is unknown.Concomitant devices reported: unknown recon screw (part # unknown, lot # unknown, quantity unknown) unknown locking screw (part # unknown, lot # unknown, quantity unknown) and unknown end cap (part # unknown, lot # unknown, quantity 1).This is report 1 of 1 for complaint (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.H10 additional narrative: h6: customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image provided.The image was reviewed, and the complaint condition could be confirmed.After reviewing the image of the nail, it was seen that the nail was broken.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.

• Brand Name: 10MM / TI CANN FRN / GT 380MM / RIGHT - 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: 9728357
• Report Number: 2939274-2020-00913
• Device Sequence Number: 19358043
• Product Code: HSB
• UDI-Device Identifier: 10886982272010
• UDI-Public: (01)10886982272010
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.033.068S
• Device Catalogue Number: 04.033.068S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 02/26/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - END CAPS; UNK - SCREWS: LOCKING; UNKNOWN RECON SCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 102