MAUDE Adverse Event Report: RAYNHAM HAND DRILL; CRANIAL HAND DRILL

Model Number	826607
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hand drill (id 826607) was returned for evaluation.Device history record (dhr) - there is no indication that the production process may have contributed to this complaint.Failure analysis - the quality engineering confirmed that there was rust present on the effected lot.Therefore, the complaint condition could be confirmed.The root cause was unable to be confirmed in the complaint evaluation.Likely root cause: destruction of the nickel protective coating, which exposed the underlying metals to the environment.This allows oxygen to react with iron causing the formation of rust.
Event or Problem Description
A facility reported rust on the base of a hand drill (id 826607) during a stock check of inventory.The hand drills were not used in a kit.No patient involvement.

• Brand Name: HAND DRILL
• Common Device Name: CRANIAL HAND DRILL
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17098231
• Report Number: 3014334038-2023-00085
• Device Sequence Number: 12715917
• Product Code: GWM
• UDI-Device Identifier: 10381780520337
• UDI-Public: 10381780520337
• Combination Product (Y/N): N
• PMA/510(K) Number: K914479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2023

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 Model Number: 826607
• Device Catalogue Number: 171881001
• Device Lot Number: 87156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown