MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY¿ TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_WWA

Device Problems Shipping Damage or Problem (1570); Component Missing (2306)

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

Event Date 03/09/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that one complete case of instruments (3 of 4 were delivered) was not delivered by the shipping company.This was noticed immediately before the surgical procedure.However, on the delivery bill from the order, these are listed as complete.Due to this, the surgery could not be performed.The patient was already anesthetized and had already had all the medical accesses required for the surgery (e.G., indwelling venous catheter, pain catheter, etc.) applied.

Event Description

It was reported that one complete case of instruments (3 of 4 were delivered) was not delivered by the shipping company.This was noticed immediately before the surgical procedure.However, on the delivery bill from the order, these are listed as complete.Due to this, the surgery could not be performed.The patient was already anesthetized and had already had all the medical accesses required for the surgery (e.G., indwelling venous catheter, pain catheter, etc.) applied.

Manufacturer Narrative

The complaint could be confirmed, based on the response from freight forwarder opc.Statement from freight forwarder opc received through distribution: the freight forwarder opc has confirmed that the barcode label has come loose/peeled off and this has caused delays.Corrective measures were initiated by opc, from now on there will be a double check as to whether the barcode label is present, i.E.The driver checks when picking up from stryker and then it will be also checked when delivering to opc.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling was not possible because the catalog number and lot number were not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.Based on investigation, the root cause was attributed to a transport/storage issue.If more information is provided, the case will be reassessed.

• Brand Name: INFINITY¿ TOTAL ANKLE SYSTEM
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13978086
• MDR Text Key: 288398847
• Report Number: 3010667733-2022-00145
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/27/2022

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: UNK_WWA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 05/03/2022
• Supplement Dates FDA Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization