MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE RP CR ARTIC SURF SZ5; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number	254500565
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This instrument is composed of 1 part.There is a spring missing.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).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, "this instrument is composed of 1 part.There is a spring missing".The product was not returned to depuy synthes, however photos were provided for review.See attachment (b)(4).The photo investigation revealed that one of the posts of 254500565, attune rp cr artic surf sz5 was spring missing from one of the post, the post also can be seen in broken chipped condition and functionality issues can not be evaluated through a photo investigation.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.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 254500565, attune rp cr artic surf sz5 would contribute to the complained device issue.Based on the investigation findings, potential cause can be traced to unintended user 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 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, "this instrument is composed of 1 part.There is a spring missing".The product was not returned to depuy synthes, however photos were provided for review.See attachment (b)(4).The photo investigation revealed that one of the posts of 254500565, attune rp cr artic surf sz5 was spring missing from one of the post, the post also can be seen in broken chipped condition and functionality issues can not be evaluated through a photo investigation.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.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 254500565, attune rp cr artic surf sz5 would contribute to the complained device issue.Based on the investigation findings, potential cause can be traced to unintended user 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 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, this instrument is composed of 1 part.There is a spring missing.As per the images attached.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that attune rp cr artic surf sz5 (254500565, mvmcjx490) has one of the post are deformed and spring are missing.No other defects were observed.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.The overall complaint was confirmed as the observed condition of the attune rp cr artic surf sz5 (254500565, mvmcjx490) 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.
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.

• Brand Name: ATTUNE RP CR ARTIC SURF SZ5
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• 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: 18495534
• Report Number: 1818910-2024-00890
• Device Sequence Number: 3665112
• Product Code: HWT
• UDI-Device Identifier: 10603295133056
• UDI-Public: 10603295133056
• Combination Product (Y/N): N
• 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: 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): 01/11/2024

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: 254500565
• Device Lot Number: MVMCJX490
• 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: 01/09/2024
• Supplement Date Received by Manufacturer: 01/16/2024; 02/14/2024; 02/21/2024; 03/12/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 01/17/2024; 02/15/2024; 02/22/2024; 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2014
• 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-2141-2015
• Patient Sequence Number: 1
• Patient Sex: Unknown