MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORDLESS DRIVER 3 HANDPIECE; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	4300000000
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported, during a procedure, metal shavings from the medical device fell into the surgical site.Metal shavings within the surgical site could potentially cause an infection.An approximate surgical delay of 5-10 minutes was noted to remove the shavings.There were no adverse consequences related to this event.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a root cause could not be determined for the event.: device not returned.
Event or Problem Description
The user facility reported, during a procedure, metal shavings from the medical device fell into the surgical site.Metal shavings within the surgical site could potentially cause an infection.An approximate surgical delay of 5-10 minutes was noted to remove the shavings.There were no adverse consequences related to this event.

• Brand Name: CORDLESS DRIVER 3 HANDPIECE
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9005775
• Report Number: 0001811755-2019-02955
• Device Sequence Number: 2802340
• Product Code: ERL
• UDI-Device Identifier: 07613154641284
• UDI-Public: 07613154641284
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2019

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 Catalogue Number: 4300000000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1