MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 PROX REAMING GUIDE DIA 12 MM; EXTREMITY INSTRUMENTS : PIN GUIDES

Catalog Number	230774012
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
Date of Event	04/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 prox reaming guide 2307-74-012 stuck in humerus.Holder 2307-74-001 would not remove guide.Doctor did a osteotome which allowed guide to be removed.After osteotome, holder was reattached to guide for removal.

• Brand Name: PROX REAMING GUIDE DIA 12 MM
• Common Device Name: EXTREMITY INSTRUMENTS : PIN GUIDES
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 7523876
• Report Number: 1818910-2018-59898
• Device Sequence Number: 1626629
• Product Code: LXH
• UDI-Device Identifier: 10603295116165
• UDI-Public: 10603295116165
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2018

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: 230774012
• Initial Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR