MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 4.2MM RADIOLUCENT DRILL BIT; BIT, SURGICAL

Catalog Number 4200355042

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 07/10/2023

Event Type  malfunction  

Event Description

The user facility reported that the packaging was observed to be unsealed prior to opening.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.

Manufacturer Narrative

H6: a follow up report will be filed once the quality investigation is complete.

Manufacturer Narrative

H6: the quality investigation is complete.

Event Description

The user facility reported that the packaging was observed to be unsealed prior to opening.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.

• Brand Name: 4.2MM RADIOLUCENT DRILL BIT
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 17468851
• MDR Text Key: 320497819
• Report Number: 3015967359-2023-01771
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 04546540348593
• UDI-Public: 04546540348593
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4200355042
• Device Lot Number: 23130027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2023
• 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