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

Catalog Number	212862100
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported event.The investigation findings attributed the root cause to unintended user error and did not indicate that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.
Event or Problem Description
It was reported that the surgeon pre drilled pins with a 3.2 mm drill bit.The drill bit got stuck in the second hole.We used the cutting guide as planned and there was no delay to the case.No surgical delay.

• Brand Name: ADV+ CUTTING GUIDE LT
• Common Device Name: EXTREMITY INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9106629
• Report Number: 1818910-2019-105832
• Device Sequence Number: 2487134
• Product Code: LXH
• UDI-Device Identifier: 10603295089803
• UDI-Public: 10603295089803
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2019

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: Health Professional
• Device Catalogue Number: 212862100
• Device Lot Number: NW144795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1