MAUDE Adverse Event Report: TORNIER INC TORNIER HRS ASSEMBLY SCREW 20MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	ARS655102
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Fall (1848); Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient complained of "grinding" with movement during post-operative visits.A fall resulted in a fracture of the greater tuberosity, requiring surgical intervention.During fracture fixation, it was observed that the proximal body had loosened from the stem.Further inspection revealed that while the locking cap was fully seated, the screw had loosened from the distal stem.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient complained of "grinding" with movement during post-operative visits.A fall resulted in a fracture of the greater tuberosity, requiring surgical intervention.During fracture fixation, it was observed that the proximal body had loosened from the stem.Further inspection revealed that while the locking cap was fully seated, the screw had loosened from the distal stem.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.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 labeling did not indicate any abnormalities.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.If device is returned or any further information is provided the complaint report will be updated.

• Brand Name: TORNIER HRS ASSEMBLY SCREW 20MM
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 20400004
• Report Number: 0001649390-2024-00579
• Device Sequence Number: 3351646
• Product Code: HSD
• UDI-Device Identifier: 00846832093267
• UDI-Public: 00846832093267
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K181420
• 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): 11/25/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: ARS655102
• Device Lot Number: AZ2323118103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Male