MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 6MM; SCREW FIXATION INTRAOSSEOUS

Model Number 401.043E

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

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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 on (b)(6) 2014 the patient had surgery for debridement of intraoral wound/infection and removal of bone and new hardware due to increase pain and loss of the skin paddle of flap and exposed.Two (2) 4 hole mini locking plates were removed and one (1) 2.0mm ti cortex self-tapping and two (2) 2.0mm ti cortex coarse pitch self-tapping were removed during hardware removal surgery.The patient's original implant date was (b)(6) 2014.This complaint addresses the second revision surgery due intraoral wound/infection and due to increase pain and loss of the skin paddle of flap and exposed.The first revision due to broken mandibular plate has been captured under linked complaint (b)(4).Third surgery for bone transplant and replacement of hardware due to unknown reason has been captured under linked complaint (b)(4).This report is for one (1) 2.0mm ti cortex screw recess 6mm.This is report 3 of 5 for complaint (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.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.

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.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.

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.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

Patient had a revision procedure due to pain and broken hardware.On (b)(6) 2014 the patient presented with severe facial swelling; the patient was not able to swallow medications or food.It was noted the patient had a post-operative fever, was warm to the touch; the right side of the face was tender; there was chapping of the lips and the oral membranes were somewhat dry.The patient was discharged on (b)(6) 2014.On (b)(6) 2014 the patient again presented with increased swelling, erythema, pain and fever.It was determined the patient had an infection.Clinical examination also showed loss of skin paddle of radial forearm osteocutaneous free flap and exposed hardware.The implants were removed and debridement of the site was conducted on (b)(6) 2014.The patient was discharged on (b)(6) 2014.

• Brand Name: 2.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 6MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7623272
• MDR Text Key: 111821897
• Report Number: 2939274-2018-52572
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 10887587045740
• UDI-Public: (01)10887587045740
• Combination Product (y/n): N
• PMA/PMN Number: K963546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 401.043E
• Device Catalogue Number: 401.043E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 81