MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CONV SHIM SZ3 12MM; TIBIAL INSERT TRIALS

Catalog Number	254500917
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device is cracked and chipped.Patient status/ outcome / consequences: was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown; is the patient part of a clinical study: unknown.(b)(4): device property of: none, device in possession of: none.(b)(4): device property of: none, device in possession of: none (b)(4): device property of: none, device in possession of: none.(b)(4): device property of: none, device in possession of: none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.: true.
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).Investigation summary - according to the information received, "items are cracked and have chips".The product was not returned to depuy synthes, however photo was provided for review.See attachment ¿31¿, ¿32¿, ¿33¿, ¿34¿, ¿35¿, ¿36¿, ¿37¿ and ¿38¿.The photo investigation revealed that 254500917, attune conv shim sz3 12mm is cracked around the metal insert and the edges of the device are chipped off.The thermal properties of the metal bushing and radel trial body are different resulting in the material to expand and contract at different rates.This puts a significant amount of stress on interfacing materials.Radel, being highly brittle, will succumb to these thermal stresses in the form of stress cracking.This cracking can be accelerated by high frequency autoclave cycles and/or the use of harsh chemicals, however, it is recognized these outside contributing factors act as a catalyst to the propagation of the cracks which ultimately can lead to catastrophic failure of the shims.Due to crack propagation being recognized as an inherent risk of the shims after repeated use, the potential cause is traced to end of life.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.¿ since the device was not returned, a dimensional inspection cannot be performed.¿ the overall complaint was confirmed as the observed condition of the 254500917, attune conv shim sz3 12mm would contribute to the complained device issue.¿ based on the investigation findings, potential cause can be traced to end of device life 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: according to the information received, "items are cracked and have chips".The product was not returned to depuy synthes, however photo was provided for review.The photo investigation revealed that 254500917, attune conv shim sz3 12mm is cracked around the metal insert and the edges of the device are chipped off.The thermal properties of the metal bushing and radel trial body are different resulting in the material to expand and contract at different rates.This puts a significant amount of stress on interfacing materials.Radel, being highly brittle, will succumb to these thermal stresses in the form of stress cracking.This cracking can be accelerated by high frequency autoclave cycles and/or the use of harsh chemicals, however, it is recognized these outside contributing factors act as a catalyst to the propagation of the cracks which ultimately can lead to catastrophic failure of the shims.Due to crack propagation being recognized as an inherent risk of the shims after repeated use, the potential cause is traced to end of life.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 254500917, attune conv shim sz3 12mm would contribute to the complained device issue.Based on the investigation findings, potential cause can be traced to end of device life 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 : according to the information received, items are cracked and have chips.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that attune conv shim sz3 12mm (254500917, bfa0rdx) is cracked around the metal insert and the edges of the device are chipped off.The thermal properties of the metal bushing and radel trial body are different resulting in the material to expand and contract at different rates.This puts a significant amount of stress on interfacing materials.Radel, being highly brittle, will succumb to these thermal stresses in the form of stress cracking.This cracking can be accelerated by high frequency autoclave cycles and/or the use of harsh chemicals, however, it is recognized these outside contributing factors act as a catalyst to the propagation of the cracks which ultimately can lead to catastrophic failure of the shims.Due to crack propagation being recognized as an inherent risk of the shims after repeated use, the potential cause is traced to end of life.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.The overall complaint was confirmed as the observed condition of the attune conv shim sz3 12mm (254500917, bfa0rdx) would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.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: according to the information received "items are cracked and have chips".The product was not returned to depuy synthes.However, photo was provided for review.The photo investigation revealed, that 254500917, attune conv shim sz3 12mm, is cracked around the metal insert and the edges of the device are chipped off.The thermal properties of the metal bushing and radel trial body are different.Resulting in the material to expand and contract at different rates.This puts a significant amount of stress on interfacing materials.Radel, being highly brittle, will succumb to these thermal stresses in the form of stress cracking.This cracking can be accelerated by high frequency autoclave cycles and/or, the use of harsh chemicals.However, it is recognized, these outside contributing factors act as a catalyst to the propagation of the cracks.Which ultimately, can lead to catastrophic failure of the shims.Due to crack propagation being recognized, as an inherent risk of the shims after repeated use.The potential cause, is traced to end of life.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use.The device must be properly inspected, prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions and inspection procedures.Since, the device was not returned.A dimensional inspection cannot be performed.The overall complaint was confirmed.As the observed, condition of the 254500917, attune conv shim sz3 12mm, would contribute to the complained device issue.Based on the investigation findings, potential cause can be traced to end of device life.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.

• Brand Name: ATTUNE CONV SHIM SZ3 12MM
• Common Device Name: TIBIAL INSERT TRIALS
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17954633
• Report Number: 1818910-2023-21245
• Device Sequence Number: 17894412
• Product Code: HWT
• UDI-Device Identifier: 10603295134947
• UDI-Public: 10603295134947
• 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,Followup
• Report Date (Section B): 10/18/2023

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: 254500917
• Device Lot Number: BFA0RDX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 11/01/2023; 02/21/2024; 03/07/2024; 03/14/2024
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/01/2023; 02/28/2024; 03/13/2024; 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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