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

Model Number	2128-62-100
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
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
It was reported as "product code: 212862100, lot# nw164287 received june 14, 2021.Salesman was contacted though a follow up, due to the product code not matching what was received for (b)(4).Salesman did not respond.Database was searched and could not find a match.Please create a new complaint to accommodate this device.All follow-up should be directed to t-239.Failure: fixation pin stuck in the guide.".
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : examination of the returned instrument confirmed the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• 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: 12242514
• Report Number: 1818910-2021-16366
• Device Sequence Number: 5402890
• Product Code: HTZ
• UDI-Device Identifier: 10603295089803
• UDI-Public: 10603295089803
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2021

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 Model Number: 2128-62-100
• Device Catalogue Number: 212862100
• Device Lot Number: NW164287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1