MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED 4.5MM LOCKING SCREW 32 MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWD032
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned as it remains in the patient.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
Patient underwent a routine reverse total shoulder.Postop images showed a sliver of twisted metal.

• Brand Name: AEQUALIS REVERSED 4.5MM LOCKING SCREW 32 MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• MDR Report Key: 12328587
• Report Number: 3000931034-2021-00308
• Device Sequence Number: 4712903
• Product Code: KWS
• UDI-Device Identifier: 03700386916663
• UDI-Public: 03700386916663
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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
• Report Date (Section B): 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DWD032
• Device Catalogue Number: DWD032
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1