MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ADV+ CUTTING GUIDE RT; EXTREMITY INSTRUMENTS : RESECTION BLOCKS/DEVICES

Catalog Number	212862110
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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
The reported device was used for the drilling with 3.2mm drill (p/n and lot number were unknown) during the surgery (date of the surgery was unknown).It was reported that the drill was stuck with reported cutting guide, so that the drill could not be come off.The surgeon removed the cutting guide together with stuck drill to complete the surgery.It was brand new and the first use when the issue occurred.There was no harm to the patient.
Additional Manufacturer Narrative
Product complaint # : (b)(4).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 the returned device 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, a follow-up medwatch will be filed as appropriate.

• Brand Name: ADV+ CUTTING GUIDE RT
• Common Device Name: EXTREMITY INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 7863864
• Report Number: 1818910-2018-68898
• Device Sequence Number: 13787708
• Product Code: HSD
• UDI-Device Identifier: 10603295089810
• UDI-Public: 10603295089810
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2018

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: 212862110
• Device Lot Number: NW164291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 09/21/2018; 11/08/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 10/16/2018; 11/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1