MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX26MM NON STERILE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number DWJ326

Device Problems Break (1069); Fracture (1260); Mechanical Jam (2983)

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

Event Date 11/23/2022

Event Type  malfunction  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.Device disposition is unknown.

Event Description

It was reported that 3 peripheral screws broke off at the neck of the screw while implanting.All 3 incident have been the exact same scenario in all 3 cases the surgeon drilled the peripheral screw hole and then measured for screw depth and started to implant corresponding screw.Once the screw was about 90% implanted it would stopped turning.The surgeon in each scenario then attempted to back out the screw and it would not back out or advance any more.The surgeon then continued trying to back out the screw until it finally snapped 3-4 threads down the screw.The surgeon went about a normal technique to complete the surgery.All the debris was successfully removed from the field/patient.Products will not be returning.

Event Description

It was reported that 3 peripheral screws broke off at the neck of the screw while implanting.All 3 incident have been the exact same scenario in all 3 cases the surgeon drilled the peripheral screw hole and then measured for screw depth and started to implant corresponding screw.Once the screw was about 90% implanted it would stopped turning.The surgeon in each scenario then attempted to back out the screw and it would not back out or advance any more.The surgeon then continued trying to back out the screw until it finally snapped 3-4 threads down the screw.The surgeon went about a normal technique to complete the surgery.All the debris was successfully removed from the field/patient.Products will not be returning.

Manufacturer Narrative

Pending investigation review; 24feb2023 tm.The reported event could not be confirmed.The device was not returned.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX26MM NON STERILE
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16234152
• MDR Text Key: 308043853
• Report Number: 3000931034-2023-00023
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00846832088447
• UDI-Public: 00846832088447
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DWJ326
• Device Catalogue Number: DWJ326
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1