MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ADV CTA RESECTION CLAMP; RESECTION BLOCKS/DEVICES

Catalog Number	212865000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the trial stem and the resection guide could not be connected during the cta surgery on (b)(6) 2017.When the surgeon tried to connect several times, the washer in the screw section of the resection guide dropped into the patient's body.The surgeon immediately noticed and removed the washer from the patient's body.Then, finally the surgeon could connect the trial stem and the resection guide without the washer, and the osteotomy of the large nodule could be performed with no problem.It was brand new and the first use when the issue occurred.There was no surgical delay and no harm to the patient.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
product complaint #: (b)(4).Investigation summary: examination of a provided photograph confirmed the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: ADV CTA RESECTION CLAMP
• Common Device Name: RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7167583
• Report Number: 1818910-2018-50335
• Device Sequence Number: 13932736
• Product Code: HWT
• UDI-Device Identifier: 10603295089865
• UDI-Public: 10603295089865
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2017

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: 212865000
• Device Lot Number: CV0308
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/04/2018
• Initial Date Received by Manufacturer: 12/08/2017
• Supplement Date Received by Manufacturer: 01/04/2018; 05/30/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 01/16/2018; 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1