MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 3/4, 36MM DIA, +3; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	DWP2363
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the inlay luxation radiologically visible on the first day after surgery.During medical procedure regular insertion of the inlay was performed.The patient underwent a revision surgery.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: a visual inspection found the device to have a slightly deformed metal ring.Additionally, chips, gouges, and scratches are evident on the poly of the device as well.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.Based on the above investigation and provided information, the root cause was attributed to a user related issue.It appears the user did not follow the instructions in the surgical technique that instructed the user to ¿apply hand pressure to begin to engage the locking mechanism.¿ the force of using the impaction handle without applying hand pressure first when attempting to seat the baseplate was enough to deform the metal collar of the device.If any further information is provided, the complaint report will be updated.

• Brand Name: PERFORM REV INSERT SZ 3/4, 36MM DIA, +3
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17019098
• Report Number: 0001649390-2023-00116
• Device Sequence Number: 14993508
• Product Code: PHX
• UDI-Device Identifier: 00846832084463
• UDI-Public: 00846832084463
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K201315
• 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): 05/30/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: DWP2363
• Device Catalogue Number: DWP2363
• Device Lot Number: AE3282011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2022
• 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: Required Intervention
• Patient Sex: Unknown