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

Model Number	2307-60-038
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: while the reported condition was not confirmed, examination of the returned device did reveal breakage of the device.Examination of the returned ecc glenosphere trial d38mm assembly confirmed the screw component has broken off the trial body.The device is not jammed or seized as initially reported.The investigation attributed the root cause to unintended user error and did not indicate that a broader investigation or corrective action was necessary.Depuy synthes 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 will be filed as appropriate.
Event or Problem Description
It was reported that when trying to "used" glenosphere trial, screw pushed thru plastic and became unusable.All pieces retrieved.No surgical delay.

• 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: 9934119
• Report Number: 1818910-2020-10358
• Device Sequence Number: 19457279
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2307-60-038
• Device Catalogue Number: 230760038
• Device Lot Number: 5305177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1