MAUDE Adverse Event Report: TORNIER S.A.S. D.4,5MM COMPRESSION SCREW L.18MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number VDV118

Device Problem Inaccurate Information (4051)

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

Event Date 04/16/2022

Event Type  malfunction  

Manufacturer Narrative

This part is not approved for use in the united states; however a like device catalog # vdv218, 510k # k030941 was cleared in the united states.

Event Description

It was reported that the surgeon requested an 18 mm fixation screw.When opening the first package, it is evident that the screw that came inside is longer than that indicated on the label, the length of the screw was verified and it was confirmed that it is 26mm long by the measurement mark that is on the screw head.The surgeon requested a new screw of the correct size be opened.The surgery ended without a serious event and the patient does not present any problem or serious repercussion.

Event Description

It was reported that the surgeon requested an 18 mm fixation screw.When opening the first package, it is evident that the screw that came inside is longer than that indicated on the label, the length of the screw was verified and it was confirmed that it is 26mm long by the measurement mark that is on the screw head.The surgeon requested a new screw of the correct size be opened.The surgery ended without a serious event and the patient does not present any problem or serious repercussion.

Manufacturer Narrative

The reported event could not be confirmed since the screws from the same batch opened in stryker france confirm to be compliant.The good manufacture of the screws by montbonnot is not questioned at this time.The device inspection revealed the following: on the pictures, we can observe that the box was opened with the screw still in its last packaging (not used) next to it.-on the packaging label, the catalog number vdv118, l.18mm and the lot number #9771aw052 were identified (size chosen by the surgeon).-on the returned screw, the lot/serial number #5743aw was identified.The length below the head of the returned screw was measured at 26.00 mm, which corresponds to the catalog number vdv126, l.26mm.=>the references of the returned screw are different than them given on the packaging label.As one lot was packaged in june-2021 (#5743aw) and the other was packaged in december-2021 (#9771aw), at 6 month intervals, it was not possible to mix the two lots during the manufacturing.Moreover, a visual inspection was performed on three aequalis reversed compression screws vdv118 lot # 9771aw numbers 004, 097 and 082 available in stock.The length of the screws, the lot number marked on the screws and on the packaging labels were checked.No issue to report, the visual inspection confirmed that the three screws from the stock correspond to the lot# 9771aw, the catalog #vdv118 with the right length l.18mm.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by devices mix-up after packaging removal by the hcp.A review of the device history for the reported lots did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any additional information is provided, the complaint report will be updated.

• Brand Name: D.4,5MM COMPRESSION SCREW L.18MM
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15124598
• MDR Text Key: 297222028
• Report Number: 3000931034-2022-00269
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

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: VDV118
• Device Lot Number: 9771AW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 07/28/2022
• Supplement Dates Manufacturer Received: 09/08/2022
• Supplement Dates FDA Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2021
• 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