MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. CRANIAL DRILL BIT

Model Number	DDK2-2.4-30X
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2022, ad-tech medical received the (b)(6) 2022 report from distributor, nihon kohden reporting that one ddk2-2.4-30x had a hole in the pouch.This issue was discovered by the distributor before it reached the customer.There was no patient impact.Ad-tech is waiting for the product to be returned.
Event or Problem Description
On (b)(6) 2022, ad-tech medical received the (b)(6) 2022 report from distributor, nihon kohden reporting that one ddk2-2.4-30x had a hole in the pouch.There was no patient impact.
Additional Manufacturer Narrative
On september 12, 2022, ad-tech medical received the august 2022 report from distributor, nihon kohden reporting that one ddk2-2.4-30x had a hole in the pouch.This issue was discovered by the distributor before it reached the customer.There was no patient impact.Ad-tech is waiting for the product to be returned.--updated : 01-06-2023 -- the product was returned for evaluation.The alleged complaint was confirmed and it was found that the sterile barrier was breached on the inner and outer pouch.The cause and time of the damage to the pouch could not be confirmed and no root cause could be identified.The risk assessment concluded that the calculated occurrence remains "alap" (as low as possible) and no further action is needed at this time.
Event or Problem Description
On september 12, 2022, ad-tech medical received the august 2022 report from distributor, nihon kohden reporting that one ddk2-2.4-30x had a hole in the pouch.There was no patient impact.

• Brand Name: CRANIAL DRILL BIT
• Common Device Name: CRANIAL DRILL BIT
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• Manufacturer (Section G): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• Manufacturer Contact: monique-elise alamina ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 15509422
• Report Number: 2183456-2022-00018
• Device Sequence Number: 14962719
• Product Code: HBE
• UDI-Device Identifier: 00841823101167
• UDI-Public: (01)00841823101167(17)240401(10)0155667804805806
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170442
• 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,Followup
• Report Date (Section B): 01/06/2023

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
• Device Expiration Date: 04/01/2024
• Device Model Number: DDK2-2.4-30X
• Device Catalogue Number: DDK2-2.4-30X
• Device Lot Number: 804805806
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (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