MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: 5.0 MM LOCKING; SCREW, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Pulmonary Embolism (1498); Hematoma (1884); Unspecified Infection (1930)

Event Date 03/16/2022

Event Type  Injury  

Manufacturer Narrative

This report is 2 of 7 for (b)(4).Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.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.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 came to or for removal of rfna due to infection.The surgeon voiced that after nail was originally inserted patient had received heparin for a significant pe and developed a large hematoma at surgical site which ultimately lead to the wound breaking down.He believes this is what lead to the patient having an infection.Rfna was explanted and antibiotic spacer was placed.

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: b5 d1, d2a, d2b, d3, d4, g4 ¿ 510k: this report is for an unknown screws: 5.0 mm locking/unknown lot.Part and lot numbers are unknown; udi number is unknown.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

This report is 2 of 7 for (b)(4).

• Brand Name: UNK - SCREWS: 5.0 MM LOCKING
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14111404
• MDR Text Key: 289261830
• Report Number: 2939274-2022-01297
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• 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: 04/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RFNA / 11 / 400 5 DEG BEND / STERILE; UNK - SCREWS: 5.0 MM LOCKING; UNK - SCREWS: 5.0 MM LOCKING; UNK - SCREWS: 5.0 MM LOCKING; UNK - SCREWS: 5.0 MM LOCKING; UNK - SCREWS: 5.0 MM LOCKING
• Patient Outcome(s): Required Intervention