MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM TI MF CORTEX SCREW SELF-TAPPING WITH FLUTES 6MM; SCREW FIXATION INTRAOSSEOUS

Model Number 401.156E

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

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional device product code: hwc, mqn, jey.Implanted in (b)(6) 2018; exact date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.

Event Description

It was reported on an unknown date; the patient underwent hardware removal procedure due to infection.There two (2) titanium broad plate 6 holes, one (1) titanium large locking plate 12 holes, five (5) titanium coretx screw self-tapping with flutes 6mm, one (1) titanium emergency screw 6mm, five (5) titanium cortex screw coarse pitch self-tapping 12mm, two (2) titanium cortex screw coarse pitch self-tapping 14mm, one (1) titanium cortex screw coarse pitch self-tapping 10mm, four (4) titanium emergency screw 12mm implanted in (b)(6) 2018.One of the three plates implanted became infected, and patient wanted them to be removed.The procedure was successfully completed with four (4) hours surgical delay.Patient outcome was unknown.This complaint involves total twenty-one (21) devices.This complaint captures ten (10) devices.Due to system limitation remaining eleven (11) devices are captured in the related complaints (b)(4).This report is for one (1) 2.0mm ti cortex screw self-tapping with flutes 6mm.This is report 4 of 10 for complaint (b)(4).

Event Description

It was further reported that there was a surgical delay of three (3) hours with the total length of surgery time of approximately four and a half hours.The patient was under anesthesia the entire time.Patient outcome was reported as fine; suffered no adverse events.

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.

• Brand Name: 2.0MM TI MF CORTEX SCREW SELF-TAPPING WITH FLUTES 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: 8421099
• MDR Text Key: 138806912
• Report Number: 2939274-2019-56958
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 10887587046228
• UDI-Public: (01)10887587046228
• Combination Product (y/n): N
• PMA/PMN Number: K981275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 401.156E
• Device Catalogue Number: 401.156E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention