MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB CR ART SURF SZ5 CONV; TIBIAL INSERT TRIALS

Catalog Number	254501965
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Each instrument is composed of 1 part.The springs of each instrument are tangled or non-uniform.The product damage documented in this 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary according to the information received, "each instrument is composed of 1 part.The springs of each instrument are tangled or non-uniform as per the images attached".The product was not returned to depuy synthes, however photos were provided for review.See attachment (image (1).Jpg).The photo investigation revealed that attune fb cr art surf sz5 conv had a deformed spring and scratches over device surface.The failure mode is consistent with inserting an extractor device in between the trial and mating shim, and using the extractor to pry the mating devices apart during extraction of the trials.This improper technique results in damage to the spring and/or post components of the articulating surface as well as the mating shim.The attune intuition surgical technique 0612-10-512 (page 53), emphasizes the correct use of the tibial trial extractor (product code 254500138) with the trials.Furthermore, on page 51 of the surgical technique and per ifu-0902-00-836, careful inspection of the trials for damage/breakage should be performed pre and post-operative.If any damage to the balseal components is observed the trail should be replaced.In the event of instrument breakage during use, ensure that all device fragments that may have entered the surgical site are removed prior to completion of the procedure, as patient injury may result.Fell apart unattached condition can be confirmed too, as the deformed condition of the spring can lead to this type of damage.Therefore, the potential cause can be traced to a component failure.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the attune fb cr art surf sz5 conv would contribute 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 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 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.H10 additional narrative: added: d9.Corrected: h3.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, "each instrument is composed of 1 part.The springs of each instrument are tangled or non-uniform as per the images attached".The product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that attune fb cr art surf sz5 conv had a deformed spring and scratches over device surface.The failure mode is consistent with inserting an extractor device in between the trial and mating shim, and using the extractor to pry the mating devices apart during extraction of the trials.This improper technique results in damage to the spring and/or post components of the articulating surface as well as the mating shim.The attune intuition surgical technique 0612-10-512 (page 53), emphasizes the correct use of the tibial trial extractor (product code 254500138) with the trials.Furthermore, on page 51 of the surgical technique and per ifu-0902-00-836, careful inspection of the trials for damage/breakage should be performed pre and post-operative.If any damage to the balseal components is observed the trail should be replaced.In the event of instrument breakage during use, ensure that all device fragments that may have entered the surgical site are removed prior to completion of the procedure, as patient injury may result.Fell apart unattached condition can be confirmed too, as the deformed condition of the spring can lead to this type of damage.Therefore, the potential cause can be traced to a component failure.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the attune fb cr art surf sz5 conv would contribute 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 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 each instrument is composed of 1 part.The springs of each instrument are tangled or non-uniform as per the images attached.The product was returned to depuy synthes for evaluation.Visual inspection revealed that attune fb cr art surf sz5 conv had a deformed spring and scratches over the device surface.The failure mode is consistent with inserting an extractor device in between the trial and mating shim, and using the extractor to pry the mating devices apart during extraction of the trials.This improper technique results in damage to the spring and/or post components of the articulating surface as well as the mating shim.The attune intuition surgical technique 0612-10-512 (page 53), emphasizes the correct use of the tibial trial extractor (product code 254500138) with the trials.Furthermore, on page 51 of the surgical technique and per ifu-0902-00-836, careful inspection of the trials for damage/breakage should be performed pre and post-operative.If any damage to the balseal components is observed the trail should be replaced.In the event of instrument breakage during use, ensure that all device fragments that may have entered the surgical site are removed prior to completion of the procedure, as patient injury may result.Although the spring was found still placed on device, the fell apart condition can be confirmed, as the deformed patterns of the spring can lead to this type of condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune fb cr art surf sz5 conv would contribute 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 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.H11 additional narrative: corrected: d4 (primary udi number), h3.

• Brand Name: ATTUNE FB CR ART SURF SZ5 CONV
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18841432
• Report Number: 1818910-2024-05067
• Device Sequence Number: 15317973
• Product Code: HWT
• UDI-Device Identifier: 10603295423379
• UDI-Public: (01)10603295423379(10)BFA0LMM
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/05/2024

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: 254501965
• Device Lot Number: BFA0LMM
• 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: 03/01/2024
• Supplement Date Received by Manufacturer: 04/02/2024; 05/28/2024; 06/26/2024; 07/17/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/03/2024; 05/30/2024; 06/28/2024; 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2013
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2146-2015
• Patient Sequence Number: 1
• Patient Sex: Unknown