MAUDE Adverse Event Report: SYNTHES GMBH SCREW INSERTER T8 SELF-RETAINING/QC; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number 03.617.904

Device Problems Compatibility Problem (2960); Material Integrity Problem (2978)

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

Event Date 02/17/2023

Event Type  malfunction  

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.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

Device report from synthese reports an event in canada as follows: it was reported that on (b)(6) 2023, the screw inserters has become worn at the distal tip and was no longer self retaining screws reliably which needs replacement.No patient involvement and no case impacted.All of the four(4) defective shafts will be returned once new ones arrive this report is for one (1) screw inserter t8 self-retaining/qc.This is report 3 of 4 for complaint (b)(4).

• Brand Name: SCREW INSERTER T8 SELF-RETAINING/QC
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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 19380 ; 3035526892
• MDR Report Key: 16503507
• MDR Text Key: 311232710
• Report Number: 8030965-2023-02859
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 10705034717180
• UDI-Public: (01)10705034717180
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K152239
• 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: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.617.904
• Device Catalogue Number: 03.617.904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SCREW INSERTER T8 SELF-RETAINING/QC; SCREW INSERTER T8 SELF-RETAINING/QC; SCREW INSERTER T8 SELF-RETAINING/QC