MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 BROACH CORAIL AMT 11; HIP INSTRUMENTS : BROACHES

Catalog Number	L20411
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, 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.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.
Event or Problem Description
It was reported on an unknown date the broach(s) were damaged.Surgeon opened a 2nd set when the broach in the first set was damaged, but the same broach in the 2nd set was similarly damaged, so he persevered with the 2nd set.The size 11 corail broach was damaged on the connection taper and the surgeon had difficulty connecting it to the broach handle.Other broaches in the set connected easily to the broach handle.A 2nd set was opened and the size 11 broach had similar damage, so the surgeon decided to persevere with it rather than open a 3rd set.The surgeon stated that the damaged to the connection taper looked to have been caused by the calcar reamer during a previous case.Procedure was completed successfully with no surgical delay.No patient consequence.
Additional Manufacturer Narrative
Product complaint(b)(4).Investigation summary :an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification 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.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.
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: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification 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.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.
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: as per information received: "please give a detailed explanation of the event: the size 11 corail broach was damaged on the connection taper and the surgeon had difficulty connecting it to the broach handle.Other broaches in the set connected easily to the broach handle.A 2nd set was opened and the size 11 broach had similar damage, so the surgeon decided to persevere with it rather than open a 3rd set.The surgeon stated that the damaged to the connection taper looked to have been caused by the calcar reamer during a previous case" and "event outcome/how was it managed? surgeon opened a 2nd set when the broach in the first set was damaged, but the same broach in the 2nd set was similarly damaged, so he persevered with the 2nd set".The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection revealed the device with signs of usage and scratches on the overall surface of the broach corail amt 11's post.Additionally, device post was found deformed at its middle section.The observed conditions of the device are consistent with a component failure that was caused by exposure to unintended forces like assembling the device in a misaligned position, or by applying excessive force while trialing that overload the device material.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.A dimensional inspection was not performed since it was not applicable to the complaint condition.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 broach corail amt 11 would have contributed to the complained device 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.H11 additional narrative: added: g1 (manufacturing site name).Corrected: h3.

• Brand Name: BROACH CORAIL AMT 11
• Common Device Name: HIP INSTRUMENTS : BROACHES
• 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: 20904435
• Report Number: 1818910-2024-25204
• Device Sequence Number: 4070683
• Product Code: HTQ
• UDI-Device Identifier: 10603295258131
• UDI-Public: (01)10603295258131(10)SO2039853
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,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: L20411
• Device Lot Number: SO2039853
• 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: 11/22/2024
• Supplement Date Received by Manufacturer: 12/20/2024; 01/03/2025; 01/12/2025; 01/20/2025; 02/06/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 12/23/2024; 01/07/2025; 01/14/2025; 01/21/2025; 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2021
• 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