MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE BASIC PACK (BPFGA)176; GENERAL SURGERY TRAY (KIT)

Model Number SBA38BPFGA

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

The device history record was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the defect described by the customer.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The component was manufactured on 03/28/2020.The actual device or images were not submitted for evaluation.Since the actual device was not received for evaluation, the condition reported could not be confirmed.A gemba walk was performed in the manufacturing area with the multifunctional team (quality, manufacturing, engineering) and determined that this defect could not occur at the manufacturing floor or during the packaging and shipping step.It is important to note that this component is sold as a raw material, and it¿s packaged as bulk; the component is subjected to a subsequent process, therefore it is not possible to determine the exact root cause of the issue.The current molding process conditions were reviewed, and it was confirmed that all manufacturing procedures are being followed properly, no condition was found that may contribute directly to the reported condition.The failure mode reported by the customer was not confirmed, no action plan is deemed required.The current process is running according to product specifications meeting quality acceptance criteria.We will continue to monitor trends and utilize the information as part of continuous improvement.

Event Description

The tip of the yankauer broke off in the femoral canal during an anterior total hip.There was an additional surgical time of 45-55 minutes while attempting to retrieve.

• Brand Name: BASIC PACK (BPFGA)176
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer (Section G): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 11032933
• MDR Text Key: 222277573
• Report Number: 1423537-2020-00578
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10887488736808
• UDI-Public: 10887488736808
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SBA38BPFGA
• Device Catalogue Number: SBA38BPFGA
• Device Lot Number: 459789
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR