MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 ECC GLENOSPHERE TRIAL D38MM; EXTREMITY INSTRUMENTS : GLENOSPHERE TRIALS

Catalog Number	230760038
Medical Device Problem Codes	Connection Problem (2900); Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2018
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 that during trialing of the 38 ecc glenosphere, the metal threaded portion of the trial became loose and separated from the plastic, making it unusable.Plastic has been stripped where metal portion threads into it.
Additional Manufacturer Narrative
(b)(4) 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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ECC GLENOSPHERE TRIAL D38MM
• Common Device Name: EXTREMITY INSTRUMENTS : GLENOSPHERE TRIALS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 7691274
• Report Number: 1818910-2018-64509
• Device Sequence Number: 16369740
• Product Code: LXH
• UDI-Device Identifier: 10603295115960
• UDI-Public: 10603295115960
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2018

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: 230760038
• Device Lot Number: 5225780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1