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
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Laxity (4526)
Date of Event	10/13/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3000931034-2021-00336
• Device Sequence Number: 3992820
• Product Code: KWS
• UDI-Device Identifier: 03700386917097
• UDI-Public: 03700386917097
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K050316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2026
• 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female