MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1/4" LOCKING KEYLESS CHUCK

Catalog Number	4505133000
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the device had metal shavings coming out during re-processing.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: 1/4" LOCKING KEYLESS CHUCK
• Common Device Name: 1/4" LOCKING KEYLESS CHUCK
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8701545
• Report Number: 0001811755-2019-02042
• Device Sequence Number: 2308962
• Product Code: HWE
• UDI-Device Identifier: 07613327304565
• UDI-Public: 07613327304565
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2019

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: No Information
• Device Catalogue Number: 4505133000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1