MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PIN COLLET (2.0-3.2MM); INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	7203136000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Reported events: 1 event was reported for this quarter.Product return status: 1 device was received for evaluation.Evaluation status: 1 event was confirmed during testing, - 1 device was found to be affected by a fracture problem.Product disposition: this device is not repairable and was not returned to the user facility.Additional information: there were no remedial actions taken on this device.This device is not labeled for single-use.
Event or Problem Description
This report summarizes 1 malfunction event in which the device fractured; 1 event had no patient involvement; no patient impact.

• Brand Name: PIN COLLET (2.0-3.2MM)
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7715375
• Report Number: 0001811755-2018-01390
• Device Sequence Number: 13857807
• Product Code: HWE
• UDI-Device Identifier: 04546540640192
• UDI-Public: 04546540640192
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/24/2018

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: 7203136000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1