MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE HUMERAL; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number YKAD7001

Device Problems Delivered as Unsterile Product (1421); Problem with Sterilization (1596)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2022

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device disposition unknown.

Event Description

It was reported that tears (hole) on the blue wrap caused the kit to become de-sterile.Patient was woken up.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned, and no other evidence were provided for investigation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.Also, kits do not have dhr¿s.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that tears (hole) on the blue wrap caused the kit to become de-sterile.Patient was woken up.

Manufacturer Narrative

Please note the following corrections: d3 (manufacturer entity) and g1 (manufacturing site).

Event Description

It was reported that tears (hole) on the blue wrap caused the kit to become de-sterile.Patient was woken up.

• Brand Name: AEQUALIS FLEX REVIVE HUMERAL
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER 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: 14146773
• MDR Text Key: 290064097
• Report Number: 3004983210-2022-00052
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: YKAD7001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 06/16/2022; 09/07/2023
• Supplement Dates FDA Received: 07/13/2022; 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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