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

Catalog Number	230760038
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device revealed breakage.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.The complaint sample consists of: (1) 230760038 ecc glenosphere trial d38mm, lot number 5308426.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 screw component and all pieces of the device were returned.The material of the trial body around the screw hole is torn, but still attached.The damage suggests the screw component was pulled upward through the trial body component during excessive tightening of the screw during assembly with a mating cup.The overall condition of the trial indicates moderate usage over the life of the device.The root cause of the breakage is being attributed to unintended user error by overtightening the screw component during assembly with a mating cup.A complaint database search finds no additional reported events against the complaint sample product and lot combination.A search of the complaint database by product code 23076038 did not identify a trend of missing/broken off screw components.The root cause of the breakage is being attributed to unintended user error.Based on the investigation findings of unintended user error as the root cause, the need for corrective action is not indicated.Complaint trends will be monitored by post market surveillance through sep-419.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 attempting to attached the handle to 38 ecc glenosphere trial, the metal connection pushed through plastic and became unusable.No surgical delay.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision depuy synthes of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : examination of the returned device revealed breakage.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.Device history lot : null.Device history batch : null.Device history review : null.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: 9362400
• Report Number: 1818910-2019-117540
• Device Sequence Number: 11414802
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

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: 5308426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR