MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM TI CORTEX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 5MM; SCREW, FIXATION, INTRAOSSEOUS

Model Number 401.062E

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

Patient Problems Nerve Damage (1979); Unspecified Musculoskeletal problem (4535)

Event Type  Injury  

Event Description

It was reported that on an unknown date patient inquiring about recalls on parts used on a total left tmj replacement done on (b)(6) 2011.Patient have attached screen shots of the information he have.His jaw has moved over to the right now, it¿s hard to chew and nobody wants to touch it because they aren¿t the original surgeon.There is no further information.This report is for one (1) 2.0mm ti cortex screw slf-drlg w/plusdrive(tm) recess 5mm.This is report 2 of 10 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: patient.Without a lot number the device history records review could not be completed.Product was not returned.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.

• Brand Name: 2.0MM TI CORTEX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 5MM
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• 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: 15146434
• MDR Text Key: 297049672
• Report Number: 2939274-2022-03079
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 10887587046037
• UDI-Public: (01)10887587046037
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 401.062E
• Device Catalogue Number: 401.062E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2022
• 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
• Patient Outcome(s): Required Intervention