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

Catalog Number ARS655101

Device Problems Device Markings/Labelling Problem (2911); Inaccurate Information (4051)

Patient Problem Insufficient Information (4580)

Event Date 05/10/2023

Event Type  malfunction  

Event Description

It was reported that the assembly screw was too short and would not engage into the revive stem when passed through the revive proximal body.The screw was found to be measuring approximately 30mm instead of the typical 40mm.An alternative implant construct was required to be utilized which was not ideal for the patient and required longer implant construct of 160mm instead of the required 130mm was utilized as a result of this incident.This resulted in additional distal humeral bone being lost to facilitate this.

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.

Manufacturer Narrative

Correction: component code.The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: a device inspection 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 photos sent clearly show the screw is a ars655118 ¿0mm short screw¿ which will not function properly for this case.Dimensional inspection: the dimensional inspection of the returned device revealed the length of the screw.Measured length = 30mm.Required length = 36.5mm.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.

Event Description

It was reported that the assembly screw was too short and would not engage into the revive stem when passed through the revive proximal body.The screw was found to be measuring approximately 30mm instead of the typical 40mm.An alternative implant construct was required to be utilized which was not ideal for the patient and required longer implant construct of 160mm instead of the required 130mm was utilized as a result of this incident.This resulted in additional distal humeral bone being lost to facilitate this.

• 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: 17070343
• MDR Text Key: 316977754
• Report Number: 0001649390-2023-00124
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00846832093250
• UDI-Public: 00846832093250
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K181420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

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
• Device Operator: 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?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 08/03/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention