MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	04.632.745
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product codes: kwp, kwq, nkb, and mnh.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 or Problem 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), ti matrix top loading polyaxial head (part 04.632.001, lot unknown, quantity 1).This report involves one (1) 7.0mm ti matrix polyaxial screw 45mm thread length.This is report 3 of 3 for (b)(4).
Additional 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.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.
Additional 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.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.

• Brand Name: 7.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10580185
• Report Number: 2939274-2020-04298
• Device Sequence Number: 2410094
• Product Code: MNI
• UDI-Device Identifier: 10705034745671
• UDI-Public: (01)10705034745671
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.632.745
• Device Catalogue Number: 04.632.745
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 10/08/2020; 10/08/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 10/19/2020; 10/27/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX; TI MATRIX TOP LOADING POLYAXIAL HEAD; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: SPINE
• Patient Age: 66 YR