MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US XTNDGLENO D42MM +0MM SHRTPST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	130761142
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
It was reported that intraoperatively it had not been possible to insert the glenosphere.Another glenosphere was used; also with this one the insertion was difficult, but it worked.Surgical delay of twenty-five minutes; no adverse patient consequences.
Additional Manufacturer Narrative
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.Additional narrative: d4.
Additional 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.H11 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: intraoperatively it had not been possible to insert the glenosphere.Another glenosphere was used; also, with this one the insertion was difficult, but it worked.Surgical delay 25 minutes, no adverse patient consequences.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed that the xtndgleno d42mm +0mm shrtpst was found cross-threaded from the driving recess and the distal portion of the screw.Additionally, the surface displays marks which are consistent with the implantation attempts.A manufacturing record evaluation was performed for the finished device [130761142/ d23043647], and no non-conformances or manufacturing irregularities were identified.The observed damaged condition suggests that the glenosphere was not properly aligned with the metaglene and excessive or off-axis forces were applied.This would contribute to the difficulty/inability to mate the glenosphere with the mating component following multiple insertion attempts.As per delta xtend¿ reverse shoulder system surgical technique "proper alignment between the glenosphere and metaglene is absolutely essential to avoid cross threading between the components.Proper alignment leads to smooth thread engagement and easy screwing.If the glenosphere seems difficult to thread onto the metaglene, do not force engagement but re-align the components".The mating metaglene component was not returned, therefore, a functional test was not able to be performed.However, due to the visual damage observed, the difficulty/inability to assemble mating devices can be confirmed.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the xtndgleno d42mm +0mm shrtpst would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to unintended use error, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: 1) quantity manufactured: (b)(4).2) date of manufacture: 23-apr-2023.3) any anomalies or deviations identified in dhr: none.4) expiry date: 31-mar-2028.5) ifu reference: ifu-w90930.Device history review: a manufacturing record evaluation was performed for the finished device [130761142/ d23043647], and no non-conformances or manufacturing irregularities were identified.H11 additional narrative: corrected: h3, h4.

• Brand Name: XTNDGLENO D42MM +0MM SHRTPST
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21631829
• Report Number: 1818910-2025-04111
• Device Sequence Number: 7536019
• Product Code: PHX
• UDI-Device Identifier: 10603295502562
• UDI-Public: (01)10603295502562(17)20280331(17)D23043647
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

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: 130761142
• Device Lot Number: LOT D23043647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 03/18/2025; 03/25/2025; 04/09/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 03/18/2025; 03/26/2025; 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown