MAUDE Adverse Event Report: DEPUY IRELAND 9616671 DELTA CTA HEAD REAMING GUIDE; EXTREMITY INSTRUMENTS : SIZING/MEASURING INSTRUMENTS

Model Number	2307-82-001
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2020
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
Delta xtend: during the case, cta reaming guide jammed with the cta reamer.Causing the reamer to not spin in the reaming guide.Reaming guide removed with reamer and the case continued as per normal.No time added to the case as the instrument was done with at that stage.Was very difficult and took a lot of effort to remove the reamer from the reaming guide - done with a hammer.No adverse outcomes expected.No patient demographic is available.Instrument separated and steribagged individually ready for return.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: DELTA CTA HEAD REAMING GUIDE
• Common Device Name: EXTREMITY INSTRUMENTS : SIZING/MEASURING INSTRUMENTS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 10532212
• Report Number: 1818910-2020-20040
• Device Sequence Number: 14253873
• Product Code: LXH
• UDI-Device Identifier: 10603295116349
• UDI-Public: 10603295116349
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020

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: 2307-82-001
• Device Catalogue Number: 230782001
• Device Lot Number: 5225815
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1