MAUDE Adverse Event Report: TORNIER INC TORNIER HRS ASSEMBLY SCREW 0MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	ARS655101
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported that while trying to assemble the implant, it was detected that the screw was of such a short length that it did not join or assemble the two pieces.A second implant of the same reference was opened that came with the same defect.And then, it was decided to use a longer stem, whose assembly screw was correctly.
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Additional Manufacturer Narrative
The reported event could be confirmed.A review of the returned affected devices clearly shows the discrepancy in the devices noted to be received by the complaint reporter and the devices that should have been received.A device inspection revealed that the screws provided for the case were confirmed to be the 0mm short screws.There are two 0mm assembly screws marketed for the tornier hrs system.Catalog # ars655101 corresponds to the screw that is 36.5mm in length.Catalog # ars655118 corresponds to the ¿short¿ screw that is 26.5mm in length.The returned devices are clearly etched with ¿0s¿ which corresponds to the ars655118 ¿0mm short screw¿.This screw was not the proper screw for this case.Dimensional inspection revealed the returned devices to be under the required dimensions for the ars655101.The overall dimensions confirmed the devices to be the ars655118 0mm short screw.A review of the labeling and device history for the reported lot did not indicate any abnormalities.No indications of material or design related problems were found during the investigation.This event has been escalated to a capa within our quality system for further investigation.Based on the investigation, the root cause was attributed to a manufacturing related issue.It was discovered that ars655118 lot az1822082 (quantity(b)(4)) and ars655101 lot az1322077 (quantity (b)(4)) were processed through packaging at the same time.The supplier stated they believe this is a complete swap of lots.They have opened a capa on their end to formalize the root cause and escape.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It has been reported that while trying to assemble the implant, it was detected that the screw was of such a short length that it did not join or assemble the two pieces.A second implant of the same reference was opened that came with the same defect.And then, it was decided to use a longer stem, whose assembly screw was correctly.

• Brand Name: TORNIER HRS ASSEMBLY SCREW 0MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 16934813
• Report Number: 0001649390-2023-00097
• Device Sequence Number: 7375339
• Product Code: KWS
• UDI-Device Identifier: 00846832093250
• UDI-Public: 00846832093250
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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 Catalogue Number: ARS655101
• Device Lot Number: AZ1322077
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2023
• 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