MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM TI CANCELLOUS POLYAXIAL SCREW 30MM FOR 4.0MM RODS; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Catalog Number 04.615.230S

Device Problems Activation, Positioning or Separation Problem (2906); Compatibility Problem (2960)

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

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during an unknown procedure, upon insertion of the screw into the patients vertebral body the synapse screwdriver/screw became very difficult to drive forward and began to make a grinding/creaking noise.At this point the screw was around 80% inserted and the surgeon felt that by attempting to drive the screw in any further would result in either the screw or the driver breaking in situ.It also behaved in the same way while the surgeon attempted to back the screw out by turning the driver anti-clockwise.It appeared as if the poly head of the screw was rotating around the shank of the screw without driving the screw itself forwards or backwards.As a result the driver would neither drive forward or back out the screw so surgeon had to detach the driver from the screw, insert a short rod and set screw and then helicopter the screw out by hand.The screw came out fully intact, a new screw was selected which went in without any problems and the surgery continued as planned.There was a surgical delay of thirty (30) minutes.The surgery was completed successfully with no further complications.Concomitant device reported: screwdriver (part # unknown, lot # unknown, quantity 1).This report is for one (1) 4.5mm ti cancellous polyaxial screw 30mm for 4.0mm rods.This is report 1 of 2 for complaint (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.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: part: 04.615.230y lot: 3l40061 date of manufacture: june 05, 2019 place of manufacture: brandywine part expiration date: n/a (nonsterile) no nonconformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.Visual inspection: the received cancellous screw for synapse is in a very used condition.The thread flanks of the screw are in the middle of the shaft partially flattened and have a clearly visible burr.The thread in the head has some strong stress marks and the stardrive is damaged.The anodized layer is worn away at all damages, which indicates that they were caused post-manufacturing.Dimensional inspection: checked dimensions with caliper per drawing: outer thread diameter - pass thread core diameter - pass document/specification review: drawing was reviewed to verify the relevant dimensions.Investigation conclusion: the complaint is rated as confirmed as the damaged thread flanks in the middle of the shaft would lead to an increased insertion and extraction force as complained.The exact cause of this damage cannot be defined, it can only be assumed that there was any strong contact with another device, that caused the flattening of the thread in this area.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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: 4.5MM TI CANCELLOUS POLYAXIAL SCREW 30MM FOR 4.0MM RODS
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11096619
• MDR Text Key: 240096209
• Report Number: 8030965-2020-10048
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 07611819477483
• UDI-Public: (01)07611819477483
• Combination Product (y/n): N
• PMA/PMN Number: K142838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.615.230S
• Device Lot Number: 3L40061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Date Manufacturer Received: 02/02/2021
• Patient Sequence Number: 1
• Treatment: UNK - SCREWDRIVERS