MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP C2C DRILL BIT 2.0 X 129MM; INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	4607-129-020
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during incoming inspection at a distribution centre, foreign matter was found in the sterile packaging.This event did not occur during a surgical procedure; no patient involvement or adverse consequences were reported.
Event or Problem Description
It was reported that during incoming inspection at a distribution centre, foreign matter was found in the sterile packaging.This event did not occur during a surgical procedure; no patient involvement or adverse consequences were reported.

• Brand Name: C2C DRILL BIT 2.0 X 129MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: kelsey barla ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 19834472
• Report Number: 3015967359-2024-01603
• Device Sequence Number: 7877989
• Product Code: HWE
• UDI-Device Identifier: 07613327540369
• UDI-Public: (01)07613327540369(11)240305(17)290301(10)23230037
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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: Other
• Device Catalogue Number: 4607-129-020
• Device Lot Number: 23230037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2023
• 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