MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 HUMERAL HEAD TRIAL 46X16; SHOULDER INSTRUMENT - HEAD TRIAL

Catalog Number	620046160
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Retention tabs on the humeral head trial 46x16 snapped off.No patient involvement.
Additional 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.
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.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.According to the information received, "retention tabs on the humeral head trial 46x16 snapped off; broken tabs removed from back table where event ocurred and discarded by facility per hospital disposal protocols." the product was not returned to depuy synthes, however photos were provided for review.See attachment ¿img_6370.Jpg¿.The photo investigation revealed that ' 620046160, humeral head trial 46x16 had broken retention tabs.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended and excessive forces during the assembling and/or disassembling process.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the humeral head trial 46x16 would contribute to the complained device issue.Based on the investigation findings, unintended use error caused or contributed to event 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 complaint condition.As part of depuy synthes 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.
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 that 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.H10 additional narrative: added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Did it break into two or more pieces? if no, please specify the alleged deficiency of the instruments.Were they bent, stripped, cross-threaded, etc.? yes, it broke into four pieces.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary :.According to the information received, "retention tabs on the humeral head trial 46x16 snapped off; broken tabs removed from back table where event ocurred and discarded by facility per hospital disposal protocols." the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that ' 620046160, humeral head trial 46x16 had broken retention tabs.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended and excessive forces during the assembling and/or disassembling process.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the humeral head trial 46x16 would contribute to the complained device issue.Based on the investigation findings, unintended use error caused or contributed to event 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 complaint condition.As part of depuy synthes 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : retention tabs on the humeral head trial 46x16 snapped off; broken tabs removed from back table where event ocurred and discarded by facility per hospital disposal protocols.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found three (3) of the inner tabs broken and one (1) tab cracked of humeral head trial 46x16.Broken tabs were not returned for evaluation.Damage observed can be consistent with the user applying excessive leverage/torque on the device in a circular pattern while disassembling the device.Inhance¿ shoulder system surgical technique states the following: "to remove the humeral head trial, assemble the head distractor to the impactor handle and place between the resection and the humeral head.To remove the offset taper adapter trial from the humeral head trial, rotate the offset taper adapter trial counterclockwise until the ramps unlock it from the head.From the e=eject position, additional counterclockwise rotation of the offset taper adapter trial will push it up the ramp and out of the humeral head trial".A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the humeral head trial 46x16 would contribute to the complained device 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 depuy synthes 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: HUMERAL HEAD TRIAL 46X16
• Common Device Name: SHOULDER INSTRUMENT - HEAD TRIAL
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; 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 46581-0988 ; 3035526892
• MDR Report Key: 18891601
• Report Number: 1818910-2024-05640
• Device Sequence Number: 7505237
• Product Code: HWT
• UDI-Device Identifier: 10603295539216
• UDI-Public: 10603295539216
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/12/2024

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: 620046160
• Device Lot Number: 316784
• 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: 03/06/2024
• Supplement Date Received by Manufacturer: 03/15/2024; 04/15/2024; 05/15/2024; 07/04/2024; 07/09/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 03/18/2024; 04/17/2024; 05/20/2024; 07/08/2024; 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown