MAUDE Adverse Event Report: FH INDUSTRIE BE POD; BE POD 3A CANNULATED SCREW D2,5 L26

Catalog Number	268398
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
In boxes of be pod 3a d2,5 l26 screws of reference (b)(4) batch rm02408 were be pod 3a d3 l10 screws of reference (b)(4) and vice versa.No patient consequences, use of another screw box.This exchange took place on a part number and lots of screws not sold in the united states.( ce reference (b)(4) / us reference : (b)(4)).
Additional Manufacturer Narrative
The recall did not take place in the usa.There are no such references in the usa, but there are equivalent references.Fh industries procedures did not clearly define the rules for reporting incidents to fda when the devices were no longer being distributed into the us market.The vigilance officer at the time was unaware that these reporting rules had to be applied even to products that were no longer distributed in the united states and that were inactivated in the fda registration & listing database.The medwatch reports that were not filed are not connected to any recalls and had no impact on patient safety.A capa was opened to determine root cause and corrective action.

• Brand Name: BE POD
• Common Device Name: BE POD 3A CANNULATED SCREW D2,5 L26
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, 21000 ; FR 21000
• Manufacturer (Section G): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer Contact: el yazid aribi ; 6 rue nobel; quimper, 29000 ; FR 29000
• MDR Report Key: 17988297
• Report Number: 3003898228-2023-00016
• Device Sequence Number: 7222320
• Product Code: HWC
• UDI-Device Identifier: 03661489683985
• UDI-Public: 03661489683985
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K163148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace,Recall
• Type of Report: Initial
• Report Date (Section B): 10/13/2023

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: Health Professional
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: 268398
• Device Lot Number: RM02408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• 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
• Patient Sex: Unknown