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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC TORNIER HRS ASSEMBLY SCREW 0MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
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TORNIER INC TORNIER HRS ASSEMBLY SCREW 0MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED Back to Search Results
Catalog Number ARS655101
Device Problems Device Markings/Labelling Problem (2911); Inaccurate Information (4051)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2023
Event Type  malfunction  
Event Description
During surgery a screw for a flex revive size zero procedure was opened.The surgical team noticed that the length of the was not long enough to engage with the femoral component of the implant.The packaging of the screw stated that the screw was a size zero.A total of 2 size zero screws were opened.Both had the same shorter length.Implant was then changed to a thinner but longer flex revive system in order to successfully complete the procedure.No further impact to the patient has been reported by the hospital.
 
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 d4 lot, d9, h3, h6 component code the reported event of packaging ¿ missing product/component could be 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 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.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.
 
Event Description
During surgery a screw for a flex revive size zero procedure was opened.The surgical team noticed that the length of the was not long enough to engage with the femoral component of the implant.The packaging of the screw stated that the screw was a size zero.A total of 2 size zero screws were opened.Both had the same shorter length.Implant was then changed to a thinner but longer flex revive system in order to successfully complete the procedure.No further impact to the patient has been reported by the hospital.
 
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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 Key17026942
MDR Text Key316304971
Report Number0001649390-2023-00121
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K181420
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberARS655101
Device Lot NumberAZ1322077
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/10/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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