MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED MULTIDIR. SCREW D4.5 L 26 STERILE; PROSTHESIS SHOULDER JOINT METAL

Model Number MULTIDIRECTIONAL SCREW D4.5MM L 26MM

Device Problem Difficult to Remove (1528)

Patient Problems Bone Fracture(s) (1870); Joint Laxity (4526)

Event Date 10/13/2021

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.Return of the device is ongoing.

Event Description

During a reverse shoulder replacement, the surgeon attempted to remove the 4 screws inserted into the glenoid baseplate (ref (b)(4)) to adjust the position of this baseplate as the bone graft was reported to be loosened.3 screws were removed successfully but the 4th multi-directional screw (ref (b)(4)) was not able to be backed out.During the process of attempting to remove this screw, it was reported that the glenoid fractured and the baseplate came out.The surgeon proceeded to continue the operation by switching to a long post baseplate.The longer baseplate was not able to be inserted and the surgeon decided to switch to a hemi using the aequalis humeral head.

Event Description

During a reverse shoulder replacement, the surgeon attempted to remove the 4 screws inserted into the glenoid baseplate (ref dwd172) to adjust the position of this baseplate as the bone graft was reported to be loosened.3 screws were removed successfully but the 4th multi-directional screw (ref dwd126) was not able to be backed out.During the process of attempting to remove this screw, it was reported that the glenoid fractured and the baseplate came out.The surgeon proceeded to continue the operation by switching to a long post baseplate.The longer baseplate was not able to be inserted and the surgeon decided to switch to a hemi using the aequalis humeral head.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.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 for the reported lot did not indicate any abnormalities.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: AEQUALIS REVERSED MULTIDIR. SCREW D4.5 L 26 STERILE
• Type of Device: PROSTHESIS SHOULDER JOINT METAL
• 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: 12785998
• MDR Text Key: 281594747
• Report Number: 3000931034-2021-00336
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386917097
• UDI-Public: 03700386917097
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K050316
• 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: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MULTIDIRECTIONAL SCREW D4.5MM L 26MM
• Device Catalogue Number: DWD126
• Device Lot Number: AD7336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Female