MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIX TOP LOADING POLYAXIAL HEAD; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number 04.632.001

Device Problem Compatibility Problem (2960)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

Additional device product codes: kwp, kwq, nkb, and mni.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.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) 2020, the polyaxial head placement tool for matrix broke off while the surgeon was performing a l4-l5 transforaminal lumbar interbody fusion (tlif) and using matrix headless system.When the surgeon went to attach the titanium matrix top loading polyaxial head to the titanium matrix polyaxial screw he had difficulty seating the head.The surgeon then asked for an unknown mallet to impact it on.The surgeon retrieved the broken fragment and switched to a different inserter and was able to pop on the head without issue.There was no surgical delay.The procedure was successfully completed.There was no patient consequence reported.Concomitant devices reported: mallet (part number unknown, lot unknown, quantity 1), polyaxial head placement tool for matrix (part number 03.632.037, lot 6624739, quantity 1), 7.0mm ti matrix polyaxial screw 45mm thread length (part number 04.632.745, lot unknown, quantity 1).This report involves one (1) ti matrix top loading polyaxial head.This is report 2 of 3 for (b)(4).

Manufacturer Narrative

Product complaint #: (b)(4).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.H10 additional narrative: d6: date of implant provided for reporting.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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.Product was not returned.Based on the information available, it has been determined that no corrective and 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: TI MATRIX TOP LOADING POLYAXIAL HEAD
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10580121
• MDR Text Key: 208336142
• Report Number: 2939274-2020-04297
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 10705034744971
• UDI-Public: (01)10705034744971
• Combination Product (y/n): N
• PMA/PMN Number: K100952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.632.001
• Device Catalogue Number: 04.632.001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2020
• Patient Sequence Number: 1
• Treatment: 7.0MM TI MATRIX POLYAXIAL SCREW 45MM; POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: SPINE; 7.0MM TI MATRIX POLYAXIAL SCREW 45MM; POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: SPINE
• Patient Age: 66 YR