MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM TI MATRIX SCREW 50MM THREAD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 04.639.650

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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, during a spine procedure the titanium poly axial head for titanium matrix screws came off or were not applied correctly.There was no surgical delay.The procedure was successfully completed.There was no patient consequence reported.This report is for one (1) 6.0mm ti matrix screw 50mm thread length.This is report 2 of 4 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.H3, h6: a photo investigation was completed: the investigation was done based on the supplied image.The image was reviewed and the complaint condition for broken could be confirmed as the image provided shows the reduction head separated from the screw.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H3, h6: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.H3, h6: a product investigation was completed: upon visual inspection, the star drive feature and the proximal internal threads in the screw head were slightly deformed.No other visual damages were observed on the device.The functional test cannot be performed as screw insertion instruments were not returned.During visual inspection, the proximal screw head damage was observed.But there were no visual breakages were observed on the device.Therefore, the alleged broken complaint condition cannot be confirmed for the returned device.The dimensional inspection was not performed on relevant features due to the post-manufacturing damage.The earliest available to the current drawing revisions were reviewed as the lot number was unknown for the returned device.The overall complaint condition was confirmed for the received device as the screw head internal threads and star drive feature was slightly deformed.The alleged complaint condition may be caused due to the damaged proximal screw head internal features.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: 6.0MM TI MATRIX SCREW 50MM THREAD LENGTH
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10734002
• MDR Text Key: 213019558
• Report Number: 2939274-2020-04818
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034749327
• UDI-Public: 10705034749327
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.639.650
• Device Catalogue Number: 04.639.650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Date Manufacturer Received: 11/25/2020
• Patient Sequence Number: 1