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

Catalog Number ARS655101

Device Problems Packaging Problem (3007); Inaccurate Information (4051)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2023

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation, additional information will be provided in a supplemental report.

Event Description

It was reported that the "revive loaner implant bank had a 0 (zero) mm assembly screw "short" included.This is not part of the standard loaner banks in canada.This screw is not able to be used as indicated with the other components in the loaner kit.The description of the assembly screw is very similar to the cdn approved screw.It was not noticed before surgery.This caused complications in the or which resulted in a smaller and longer humeral stem needed to finish the surgery for the patient." at a later date the following was added: patient¿s humeral canal was reamed to a 13mm x130mm revive stem.Ended up implanting a 15mmx150mm revive partially coated stem uncemented.Stem was stable upon implantation.Patient will be viewed in clinic in 21 days.

Event Description

It was reported that the "revive loaner implant bank had a 0 (zero) mm assembly screw "short" included.This is not part of the standard loaner banks in canada.This screw is not able to be used as indicated with the other components in the loaner kit.The description of the assembly screw is very similar to the cdn approved screw.It was not noticed before surgery.This caused complications in the or which resulted in a smaller and longer humeral stem needed to finish the surgery for the patient." at a later date the following was added: patient¿s humeral canal was reamed to a 13mm x130mm revive stem.Ended up implanting a 15mmx150mm revive partially coated stem uncemented.Stem was stable upon implantation.Patient will be viewed in clinic in 21 days.

Manufacturer Narrative

The reported event was confirmed since the device was returned for evaluation and matches the alleged failure.A device inspection revealed the following: the visual inspection of the return device confirm that the screws provided for the case were too short for the 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 device sent clearly show the screw is a ars655118 ¿0mm short screw¿ which will not function properly for this case.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, or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause was attributed to a manufacturing related issue.It was discovered that ars655118 lot az1822082 (quantity 55) and ars655101 lot az1322077 (quantity 55) 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
• Type of Device: 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: 17240888
• MDR Text Key: 318778100
• Report Number: 0001649390-2023-00158
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K181420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: ARS655101
• Device Lot Number: AZ1322077005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 08/22/2023
• Supplement Dates FDA Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female