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

Model Number 04.639.650

Device Problem Compatibility Problem (2960)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Event occurred on an unknown date in 2021.Additional procode: mnh, mni, kwq, kwp.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be 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.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 an unknown date, the 6.0mm ti matrix screw would not thread on to matrix screwdriver.Two (2) different screws were tried and neither would not attach to the screwdriver.Two different driver tips were also used to attempt to attach to the screw unsuccessfully.There was no patient consequence.This report is for one (1) 6.0mm ti matrix screw 50mm thread length.This is report 4 of 4 for (b)(4).

Event Description

Updated event description: the t25 driver tip was the item used.

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: updated data: b5, h6.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 DDD
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11279792
• MDR Text Key: 230613561
• Report Number: 2939274-2021-00682
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

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
• Device Operator: Health Professional
• Device Model Number: 04.639.650
• Device Catalogue Number: 04.639.650
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 03/01/2021
• Patient Sequence Number: 1
• Treatment: 6.0MM TI MATRIX SCREW 50MM THREAD LENGTH; DISTRACTOR TIP FOR MATRIX DETACHABLE HOLDING; T25 STARDRIVE SHAFT F/MATRIX LONG