MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX38MM NON STERILE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	DWJ338
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned as it was lost after the case.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
When the surgeon was tightening the screw, the head broke off.The broken piece was recovered and removed from the patient, but the other part of the screw is still in.There was no issue to patient nor was there a delay in surgery.
Additional Manufacturer Narrative
The device will not be returned as it was lost after the case.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
When the surgeon was tightening the screw, the head broke off.The broken piece was recovered and removed from the patient, but the other part of the screw is still in.There was no issue to patient nor was there a delay in surgery.

• Brand Name: TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX38MM NON STERILE
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: janice mithouard ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330 ; 476613500
• MDR Report Key: 13047583
• Report Number: 3004983210-2021-00088
• Device Sequence Number: 1854931
• Product Code: PHX
• UDI-Device Identifier: 00846832060979
• UDI-Public: 00846832060979
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161742
• 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): 12/20/2021

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: Health Professional
• Device Model Number: DWJ338
• Device Catalogue Number: DWJ338
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown