MAUDE Adverse Event Report: SYNTHES GMBH ROD Ø3.5 PREBENT L40 TAN GOLD; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Catalog Number 498.136

Device Problem Material Integrity Problem (2978)

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

Event Date 01/01/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in portugal as follows: it was reported that on an unknown date, patient underwent revision surgery due to broken screws.Patient was originally treated six years ago for tumor with instability in c1/c2.On an unknown postoperative date, the patient returned to the surgeon complaining of pain.Exams detected that both screws in c1 were broken.In the revision surgery, the implants were removed and new stabilization was performed with another material.This report is for one (1)rod ø3.5 prebent l40 tan gold this is report 2 of 3 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: b3: date of event is an unknown date in 2023.E3: reporter is a synthes employee.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.¿ visual analysis of the returned sample revealed that the rod ø3.5 prebent l40 tan gold was found broken, the broken fragments were not returned.The broken condition causing that the cortex polyax shaft scrw cannot be disassembled, this condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces, like usage of excessive force in a prying motion.A dimensional inspection was not performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to excessive/unintended forces.The overall complaint was confirmed as the observed condition of the 3.5mm ti cortex polyax shaft scrw 32mm would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition 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.¿ as part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Drawing/specifications reviewed: rev c current.Dimensional inspection: n/a.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: ROD Ø3.5 PREBENT L40 TAN GOLD
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 17198999
• MDR Text Key: 317998559
• Report Number: 8030965-2023-08038
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 07611819871212
• UDI-Public: (01)07611819871212
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 498.136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 3.5MM TI CORTEX POLYAX SHAFT SCRW 32MM; 3.5MM TI CORTEX POLYAX SHAFT SCRW 32MM; CANCELLOUSSCR SYNAPSE Ø3.5 L30 TAN; CANCELLOUSSCR SYNAPSE Ø3.5 L30 TAN; LOCKSCR SYNAPSE TAN; LOCKSCR SYNAPSE TAN; LOCKSCR SYNAPSE TAN