MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; SCREW, FIXATION, BONE

Device Problem Unintended Movement (3026)

Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Unknown date after (b)(6) 2018.The 510k: this report is for an unknown 4mm fully threaded cancellous screw/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient implanted with hardware on (b)(6) 2018 and was returned to surgery for revision syndesmosis repair.A non-union/delayed healing was noted.It was reported that patient was returned to surgery due to fall and disruption of previous repair.Hardware was removed and syndesmosis revised with another plate and screws.It was noted the patient had healed and was walking.Then the patient fell causing a disruption which is likely what lead to a 3.5mm cortex screw breaking and a 4mm fully threaded cancellous screw to back out.Concomitant device: one-third tubular plate with collar 2 holes/25mm (part 241.32, lot h344065, quantity 1).This report is for an unknown 4mm fully threaded cancellous screw.This is report 2 of 2 for (b)(4).

• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7533198
• MDR Text Key: 108888195
• Report Number: 2939274-2018-52239
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 146