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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI POLYAXIAL REDUCTION HEAD FOR TI MATRIX SCREWS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI POLYAXIAL REDUCTION HEAD FOR TI MATRIX SCREWS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 04.634.002
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 polyaxial 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) ti polyaxial reduction head for ti matrix screws.This is report 1 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, h4, h6: part 04.634.002, lot 44p0475: release to warehouse date: february 18, 2020.Supplier: (b)(4).No non-conformance reports (ncr's) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.H3, h6: a product investigation was completed: upon visual inspection, no visual damages were observed on the device.The functional test cannot be performed as screw insertion instruments were not returned, but there were no visual damages were observed on the device that would contribute to the alleged complaint condition.Therefore, the alleged complaint condition cannot be confirmed for the returned device.The dimensional inspection was not performed on relevant features of the collet component, since dimensional specifications are applied prior to slotting, which was no longer the state of this finished component.Further dimensional inspection of the remaining relevant features of the device could not be performed as internal mating components cannot be accessed due to assembled device geometry.The drawing reflecting the current and manufactured revision was reviewed.The complaint condition was not confirmed for the received device as no damages were observed on the device.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.
 
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Brand Name
TI POLYAXIAL REDUCTION HEAD FOR TI MATRIX SCREWS
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 Key10733972
MDR Text Key213014695
Report Number2939274-2020-04817
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034747507
UDI-Public10705034747507
Combination Product (y/n)N
PMA/PMN Number
K100952
Number of Events Reported1
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 Received10/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number04.634.002
Device Catalogue Number04.634.002
Device Lot Number44P0475
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2020
Date Manufacturer Received11/25/2020
Patient Sequence Number1
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