MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 DELTA XTEND METAGLENE POSITIONER PLATE; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	230787003
Medical Device Problem Codes	Device-Device Incompatibility (2919); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this was an unknown surgery performed on (b)(6) 2024.The surgeon used the plate in question as normal and attempted to pass a 2.5 mm metaglene guide pin through the central hole.However, the surgeon felt caught.Therefore, once the guide pin was removed from the plate in question, it was found that there were multiple scratches when looking through the central hole.The surgeon determined that it was not possible to use a 2.5 mm metaglene guide pin to pass it through, so a 2.0 mm k-wire owned by hospital was substituted.With the substitution, the surgery was completed without any problems.There was more than 30 minutes surgical delay and no harm to the patient.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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: d4 (lot), d9, h4.Corrected: d4 (primary udi number), h5.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: it was reported that this was an unknown surgery performed on (b)(6) 2024.The surgeon used the plate in question as normal and attempted to pass a 2.5 mm metaglene guide pin through the central hole.However, the surgeon felt caught.Therefore, once the guide pin was removed from the plate in question, it was found that there were multiple scratches when looking through the central hole.The surgeon determined that it was not possible to use a 2.5 mm metaglene guide pin to pass it through, so a 2.0 mm k-wire owned by hospital was substituted.With the substitution, the surgery was completed without any problems.There was more than 30 minutes surgical delay and no harm to the patient.No further information is available.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed that the metaglene positioner plate had the central hole slightly deformed.Additionally, scratches were found in the same area.The observed condition of the device appears to be a result from a combination of heavy use and exposure to unintended forces, such as prying motions applied during repeated assembly and disassembly with its mating device.A functional test was not performed since the mating device was not returned, however, based on the observed condition of the device, it is reasonable to conclude that this condition would likely impede the device from securely attach or holding its mating device.Therefore, the reported allegation 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 metaglene positioner plate would have contributed to the complained issue.Based on the investigation findings, 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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: DELTA XTEND METAGLENE POSITIONER PLATE
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21063103
• Report Number: 1818910-2025-00089
• Device Sequence Number: 8757950
• Product Code: HSD
• UDI-Device Identifier: 10603295116448
• UDI-Public: (01)10603295116448(10)5249310
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170748
• 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

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: 230787003
• Device Lot Number: 5249310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 01/23/2025; 02/10/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 01/24/2025; 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown