MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXNEURO SCREW SELF-DRILLING 4MM; BONE PLATE

Model Number 04.503.104.01

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

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 that on (b)(6) 2018, during an unknown procedure, the surgeon was implanting two (2) matrix neuro screws in the patient¿s native bone.The surgeon decided to reposition the plates and, while backing up the screws, the screw heads broke off.The plates were removed, and the proud screws were buried flush to the bone.The procedure was successfully completed.There was a surgical delay of 3 minutes.Patient status was stable.Concomitant devices reported: unk - plates: trauma (part # 04.503.023, lot # unknown, quantity # 2).This report is for one (1) ti matrixneuro screw self-drilling 4mm.This is report 2 of 2 for (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.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) 2018 in an unknown procedure, while the surgeon was implanting two (2) matrix neuro screws into the patients native bone, he decided to reposition the plates and as backing up the screws, the head broke off.The plates were removed and the proud screws were burred flush to the bone.The procedure was successfully completed.There was a surgical delay of 3 minutes.Patient status was stable.Concomitant devices reported: unk - plates: trauma (part # 04.503.023, lot # unknown, quantity # 2).

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

Further it was reported that a new implant set was opened to complete the procedure.Concomitant devices reported: titanium matrix neuro burr hole cover (part # 04.503.023, lot # unknown, quantity # 2).

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.H6: patient code 3191 used to capture additional medical/surgical intervention required: the screw broke intraoperatively.The head fragment was removed, however the shaft remains.The surgeon used a burr to make the screw shaft flush to bone.B5: corrected concomitant device.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: TI MATRIXNEURO SCREW SELF-DRILLING 4MM
• Type of Device: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8199529
• MDR Text Key: 131504748
• Report Number: 2939274-2018-55602
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587018324
• UDI-Public: (01)10887587018324
• Combination Product (y/n): N
• PMA/PMN Number: K123723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.503.104.01
• Device Catalogue Number: 04.503.104.01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR