MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 BROACH CORAIL AMT 15; HIP INSTRUMENTS : BROACHES

Catalog Number	L20415
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from depuy synthes australia reports an event as follows: during a loan kit inspection, it was found that the broach corail does not seat flat in neck trials, the fit is too tight.No other 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.Device was used for treatment, not diagnosis.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).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation, however photos were provided for review.Review of the provided photos did not confirm unable to assemble condition of device.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 the device associated with this report was not returned to depuy synthes for evaluation, however photos were provided for review.Review of the provided photos did not confirm unable to assemble condition of device.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 : broach corail does not seat flat in neck trials, to tight a fit.Pc has been identified during loan kit inspection, by the loan kit technician.The event date and alert date are the date that the inspection took place.There is no surgeon, procedure, or patient details available.No further information can be obtained as the case was not reported by the customer.The device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned item found nothing indicative of a device nonconformance that would indicate an assembling issue.Normal use marks have been identified on the device post.A functional test was performed using mating neck trail 201205200 lot pg257499 and devices were able to be fully assembled without issue.The reported does not seat flat condition was not able to be replicated.The overall complaint was not confirmed as the observed condition of the broach corail amt 15 would not contribute to the complained device issue.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: BROACH CORAIL AMT 15
• Common Device Name: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17399322
• Report Number: 1818910-2023-15285
• Device Sequence Number: 7556706
• Product Code: HTQ
• UDI-Device Identifier: 10603295258179
• UDI-Public: 10603295258179
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/26/2023

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: L20415
• Device Lot Number: 1941173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 08/16/2023; 08/23/2023; 08/25/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 08/16/2023; 08/23/2023; 08/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2019
• 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