MAUDE Adverse Event Report: TORNIER INC TORNIER HRS ASSEMBLY SCREW 40MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	ARS655104
Medical Device Problem Codes	Loss of Osseointegration (2408); Noise, Audible (3273)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Implant Pain (4561)
Date of Event	11/22/2023
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.
Event or Problem Description
As reported: "patient had a revive (implant) put in on (b)(6) 2023.Patient came back complaining of pain and a clicking.Dr.Scheduled for a revision on 22 nov 2023 and it was discovered that the assembly screw had come loose and the proximal body was rotating".
Event or Problem Description
As reported: "patient had a revive (implant) put in on (b)(6) 2023.Patient came back complaining of pain and a clicking.Dr.Scheduled for a revision on (b)(6) 2023 and it was discovered that the assembly screw had come loose and the proximal body was rotating".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the received device (screw) when inspected visually looks in good condition and shows no signs of damage.Moreover, the functional inspection was done by assembling the returned devices and it was observed the whole construct is intact & tightened, there were no signs of loosening.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.A review of the labelling did not indicate any abnormalities.Based on investigation, the probable root cause was attributed to a patient related issue.As there are multiple patient related factors such as bone condition, activity level, and/or compliance to post-surgical instructions that can contribute to component loosening.If any further information is provided, the complaint report will be updated.

• Brand Name: TORNIER HRS ASSEMBLY SCREW 40MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18352808
• Report Number: 0001649390-2023-00350
• Device Sequence Number: 8407222
• Product Code: PHX
• UDI-Device Identifier: 00846832093281
• UDI-Public: 00846832093281
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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: Lay User/Patient
• Device Catalogue Number: ARS655104
• Device Lot Number: AZ4322047052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2022
• 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 Age: 58 YR
• Patient Sex: Male