MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RFNA / 12 / 320 5 DEG BEND / STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.233.232S

Device Problems Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2022

Event Type  Injury  

Manufacturer Narrative

Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.A photo investigation was completed: visual analysis of the provided photo revealed that there was no damage or defects with the rfna nail.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 Description

It was reported that on (b)(6) 2022, the patient under a hardware removal procedure to remove the lateral oblique locking screw of the retrograde femoral nail advanced (rfna) because it had backed out.This report is for a rfna nail.This is report 1 of 2 for (b)(4).

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.H10 additional narrative: 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.H11 (corrected data): b1, b5, h1: the initial complaint was reviewed and found not reportable.

• Brand Name: RFNA / 12 / 320 5 DEG BEND / STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13824280
• MDR Text Key: 287520695
• Report Number: 2939274-2022-00951
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982290854
• UDI-Public: (01)10886982290854
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.233.232S
• Device Catalogue Number: 04.233.232S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKING SCREW FOR IM NAIL 5/ 86/ XL25; UNK - END CAPS; UNK - NUTS; UNK - SCREWS: LOCKING; UNK - WASHERS
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female