MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 MODULAR CENT EPI TRIAL SZ2; EXTREMITY INSTRUMENTS : EPIPHYSIS TRIAL

Catalog Number	230720201
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/14/2018
Type of Reportable Event	Malfunction
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 the male part of epi trial does not fit into the female part of this stem trail; male to large for female.Surgical delay of 2 mins.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Product complaint # pc-(b)(4).Investigation summary examination of the returned device 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.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MODULAR CENT EPI TRIAL SZ2
• Common Device Name: EXTREMITY INSTRUMENTS : EPIPHYSIS TRIAL
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 7582353
• Report Number: 1818910-2018-61644
• Device Sequence Number: 1523949
• Product Code: LXH
• UDI-Device Identifier: 10603295115748
• UDI-Public: 10603295115748
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup,Followup,Followup
• Report Date (Section B): 05/14/2018

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: 230720201
• Device Lot Number: 2518767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 05/14/2018; 06/15/2018; 07/30/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 06/08/2018; 06/22/2018; 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1