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

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

Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient weight was not provided for reporting.Date of event is unknown.This report is for twelve (12) unknown screws.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.Reporter contact number was not provided.This report is twelve (12) unknown screws.Pma/510(k) number is not available.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 underwent a procedure to repair an unknown mandible fracture on (b)(6) 2015.The patient had attempted to remove their own molar.Postoperatively, on (b)(6) 2015, it was identified that the patient had presented with non-union of the fracture site and an infection.On (b)(6) 2015, the patient was returned to the operating room where the surgeon removed two synthes matrixwave maxillomandibular fixation (mmf), and 12 unknown 6 mm screws.The fracture was noted to have fully healed at that time.The procedure was completed successfully.No surgical delays were reported.This report is for twelve (12) unknown screws.This is report 3 of 3 for (b)(4).

Manufacturer 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.

Event Description

It was reported that a patient underwent a procedure to repair an angular mandible fracture on (b)(6) 2015.The fracture was fracture was non-discplaced and treated strictly with mandibulo-maxillary fixation.The patient had attempted to remove their own molar.Postoperatively, on (b)(6) 2015, it was identified that the patient had presented with non-union of the fracture site and an infection not near the construct.The unknown infection was treated with multiple courses of antibiotics and the the infected area was debrided and fixed with a bicortical recon bar.On (b)(6) 2015, the patient was returned to the operating room where the surgeon removed two synthes matrixwave maxillomandibular fixation (mmf), and 12 unknown 6mm screws.The fracture was noted to have fully healed at that time.The procedure was completed successfully.No surgical delays were reported.

• 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: 7146296
• MDR Text Key: 95769699
• Report Number: 2939274-2017-50427
• 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: study
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 01/11/2018
• Supplement Dates FDA Received: 01/24/2018
• 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: 52 YR