MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DXTEND METAGLENE; DELTA XTEND IMPLANTS : SHOULDER METAGLENE

Catalog Number 130760000

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2023

Event Type  malfunction  

Event Description

Whilst screwing on the size 42 standard glenosphere, the surgeon could not engage the thread into the metaglene and initially believe the 3.5 cannulated screwdriver head was cross threaded.Due to multiple attempts, the surgeon then requested the size 42 eccentric glenosphere as the standard glenosphere had stripped its internal screw thread.The same problem was encountered with the 42 eccentric glenosphere.Surgeon believed it wasn't essentially the screwdriver but the metaglene and that it was not allowing the glenosphere screw to engage with it.The standard metaglene and screws was then removed and replaced with a 10+ metaglene and longer locking screws (changed from 2 x 36 locking screws to 2 x 42 locking screws) and leaving the same 2 x 18 non locking screws.The 42 eccentric metaglene was then replaced and there was no issues with the cannulated screwdriver when screwing it into the new metaglene.Surgeon believe it was the metaglene (standard initially used) that was the cause of the glenospheres not engaging.Both standard metaglene and 42 standard glenosphere will be cleaned by the hospital so they can be returned for investigation.Surgery was delayed 30 minutes due to this incident.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: DXTEND METAGLENE
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER METAGLENE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18118554
• MDR Text Key: 327910255
• Report Number: 1818910-2023-23029
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027737
• UDI-Public: 10603295027737
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K192855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 130760000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Female