MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 3/4 39MM DIA +0 VE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Catalog Number	DWS2390
Medical Device Problem Codes	Positioning Failure (1158); Device Difficult to Setup or Prepare (1487); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The revision surgery was conducted in response to an infection.An update provided indicates a lack of information regarding the lot numbers for the screws used.However, it was mentioned that the infection appeared to be localized, and the procedure involved washing out and exchanging parts.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device disposition unknown.
Additional Manufacturer Narrative
The reported event was confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the visual inspection of the returned device reveals slight deformation.On one of the alignments tabs a bit of poly chipped off is observed.The capture ring has minor deformations.Functional inspection: the functional test of returned poly implant was performed with the sample fixture which confirms that the implant does not seat in properly failing to meet the specified requirement for alignment.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, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.However surgical technique instructs the user to use hand pressure prior to impacting the insert which is not mentioned in this event.There is a probably that this may have led to improper implant assembling.Based on the above investigation and provided information, the root cause was attributed to user related issue.The failure appears to happen as the user did not follow the instructions in the surgical technique that instruct the ¿apply hand pressure to begin to engage the locking mechanism followed by use the impaction handle assembly to fully seat the reversed insert.¿ moreover, the deformation of the capture ring happens to occur if the surgeon impacts with high external forces prior to using hand pressure to seat the device.If any further information is provided, the complaint report will be updated.
Event or Problem Description
A poly implant encountered difficulty fitting into the stem during assembly due to a misaligned snap ring.This issue caused a 10-minute surgical delay.It was resolved by using a different implant of the same type.

• Brand Name: PERFORM REV INSERT SZ 3/4 39MM DIA +0 VE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED
• 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: 18779116
• Report Number: 0001649390-2024-00064
• Device Sequence Number: 8382587
• Product Code: PAO
• UDI-Device Identifier: 00846832078080
• UDI-Public: 00846832078080
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: DWS2390
• Device Lot Number: CZ2122343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown