MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND GLENOSPHERE STD D38MM; DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE

Model Number 130760138

Device Problems Off-Label Use (1494); Device-Device Incompatibility (2919)

Patient Problem Not Applicable (3189)

Event Date 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: the device was examined by the manufacturer and a report was received stating the root cause deterioration during installation.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.

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 Description

It was reported that this was a rtsa (reverse total shoulder arthroplasty) treating cta (cuff tear arthroplasty) on (b)(6) 2020.The surgeon screwed in the glenosphere (130760138) with the help of a guide pin.Because the glenosphere was not able to be fit in, the surgeon hammered it, which failed and required reinsertion.The glenosphere and the guide pin were removed for the reinsertion.But the guide pin did not go through the glenosphere.Another guide pin with a smaller diameter could go in.As the surgeon thought that the glenosphere¿s shaft might have distorted, s/he completed the procedure with a replacing glenosphere less than 30-minute surgical delay.There was no harm to the patient.The device was the first use when the issue occurred.

• Brand Name: DXTEND GLENOSPHERE STD D38MM
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9774896
• MDR Text Key: 188143293
• Report Number: 1818910-2020-06486
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027768
• UDI-Public: 10603295027768
• Combination Product (y/n): N
• PMA/PMN Number: K062250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130760138
• Device Catalogue Number: 130760138
• Device Lot Number: 5353857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Date Manufacturer Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1