MAUDE Adverse Event Report: TORNIER INC TORNIER HRS ASSEMBLY SCREW 0MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	ARS655101
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that there was a revision surgery with the original intent on performing a sphere/poly swap.Upon inspection, patient had a loose revive stem and needed a new one.After prep, the decision was made to go with a 130mm fully coated distal stem instead of the original partially coated stem.When putting the 0mm assembly screw down the 11mm proximal body, the 11mm distal stem wouldn't engage the screw.After minutes of trying to assemble with no success, the screw was noticeably shorter.A 0s screw was in the regular 0mm sku.This caused a time delay in case.The patient was too small to go to a 150mm length for use.With no other option available, the physician used the 0mm screw that was in the original stem.
Event or Problem Description
It was reported that there was a revision surgery with the original intent on performing a sphere/poly swap.Upon inspection, patient had a loose revive stem and needed a new one.After prep, the decision was made to go with a 130mm fully coated distal stem instead of the original partially coated stem.When putting the 0mm assembly screw down the 11mm proximal body, the 11mm distal stem wouldn't engage the screw.After minutes of trying to assemble with no success, the screw was noticeably shorter.A 0s screw was in the regular 0mm sku.This caused a time delay in case.The patient was too small to go to a 150mm length for use.With no other option available, the physician used the 0mm screw that was in the original stem.
Additional Manufacturer Narrative
Please note the corrections made to the h6 health impact code and the component code: the reported event of labeling - mislabeling was confirmed.Photos were provided for investigation and clearly shows the discrepancy in the packaged device and what device should be in the package.A device inspection was not possible since the affected device was not returned, however photos were provided for investigation.The photos confirm that the screw provided for the case is too short for the 11mm proximal body to engage with the distal stem.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 photos sent clearly show the screw is a ars655118 ¿0mm short screw¿ which will not function properly for this case.Because the alleged issue noted in this complaint required the surgeon to reuse the previous screw that was implanted, the medical expert opinion regarding this action was requested: ¿2.I also have concerns about the surgeon re-using the screw from the original implanted construct.Do you feel this action increases the risk of infection or potential implant failure to the revised construct? a.Yes, this action increases the risk of implant failure (dissociation of components).B.Yes, theoretically there is a change that the screw is contaminated and that an infection may arise because of that.¿ 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 (b)(4) and ars655101 lot az1322077 (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.

• Brand Name: TORNIER HRS ASSEMBLY SCREW 0MM
• 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: 16792206
• Report Number: 0001649390-2023-00074
• Device Sequence Number: 12182286
• Product Code: HSD
• UDI-Device Identifier: 00846832093250
• UDI-Public: 00846832093250
• 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
• 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): 07/24/2023

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: AZ1322077043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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