MAUDE Adverse Event Report: MEX15 MEXICO-TIJUANA 9 SUR 3204 CAUTERY TIPOLISHER; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	31142717
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported they opened three packages and 2 of the 3 were missing the x-ray indicator.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.The device history record (dhr) for lot 1929407164 indicates the product was manufactured on 10/29/2019.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.There were 40 unused samples received for the investigation.Upon visual inspection, one sample did not have an x-ray indicator inserted.Therefore, the reported condition is confirmed.The affected component is produced by an external supplier; the manufacturing plant assembly process only consists in a pick and place operation for this material.A notification was sent to the supplier to investigate this issue.If additional information is obtained, this file will be re-opened for further investigation.At this time, a corrective and preventive action is not deemed necessary.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.There were 40 unused samples received for the investigation.Upon a visual inspection, 1 of the samples did not have an x-ray indicator inserted; the reported condition is confirmed.The affected component is produced by an external supplier; the manufacturing plant assembly process only consists of a pick and place operation for this material.As part of continuous improvements, a formal investigation has been opened with the supplier to determine the root cause and implement the appropriate corrective actions to prevent the recurrence of the reported issue.

• Brand Name: 3204 CAUTERY TIPOLISHER
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): MEX15 MEXICO-TIJUANA 9 SUR; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 11595326
• Report Number: 9612030-2021-02831
• Device Sequence Number: 3495426
• Product Code: MDM
• UDI-Device Identifier: 10884521512658
• UDI-Public: 10884521512658
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2021

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
• Operator of Device: No Information
• Device Model Number: 31142717
• Device Catalogue Number: 31142717
• Device Lot Number: 1929407164
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 03/05/2021; 03/05/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 05/05/2021; 08/16/2021
• Patient Sequence Number: 1