MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC LARGE CHUCK WITH KEY REAMING SPEED; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number	05.001.254
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter's facility name, mailing address and phone number were not provided.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device power supply did not function and the coupling was defective.The device also failed pretest for check the machine coupling.Therefore, the reported condition was confirmed.The assignable root cause could not be determined.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Event or Problem Description
It was reported from (b)(6) that the large chuck key device was running rough.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported, however it was noted that the event occurred in 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: LARGE CHUCK WITH KEY REAMING SPEED
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7325314
• Report Number: 8030965-2018-51864
• Device Sequence Number: 151617
• Product Code: HWE
• UDI-Device Identifier: 10886982130273
• UDI-Public: (01)10886982130273(11)151110
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2018

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: Health Professional
• Device Catalogue Number: 05.001.254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Initial Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1