MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE PS FEM TRIAL SZ 5 LT; FEMORAL TRIALS

Catalog Number	254500735
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the left femoral trial broke in half when being inserted.
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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).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: photographs were provided but they do not represent the current complaint condition or a device malfunction i.E broken.According to the information received, "it was reported that the left femoral trial broke in half when being inserted." the product was not returned to medtech orthopaedics; however, photos were provided for review.See ¿(b)(4) sticker photo ad 05 nov 2024 and 05_nov_2024_22_06_28_11963.The investigation was not able to confirm the reported event as the complaint condition was not represented clearly in the provided photo.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the photographs provided are not representative of the reported complaint condition.Based on the investigation findings, no problem was detected 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 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 device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary according to the information provided, it was reported that the trial femur cracked during trialing but didn't break into more than one piece.No harm to the patient.No delay.No further information is available.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the attune ps fem trial sz 5 lt is broken in two pieces.The broken piece was returned.The fracture surface is consistent with overload due to a combination of heavy impaction and the trial fitting too tight over the posterior/anterior aspect of the resected femur bone forcing the curved features of the femoral trial to open.The combination of heavy impaction and possible discrepancies in the resection depth between the femur and the trial suggest unintended user error.Furthermore, per the attune surgical technique (dsus/jrc/0316/1437 rev.K) it is cautioned when extracting the trial, rocking the trial medio-laterally may cause condylar fracture.Such rocking should be avoided.A functional test was not performed due to the post-manufacturing damage.A dimensional inspection was not performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the attune ps fem trial sz 5 lt would have not contributed to the complained issue.Based on the investigation findings, the potential cause is traced to unintended use error caused or contributed to event, and it has been determined that no corrective and/or preventative action is required.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.Corrected: h3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: photographs were provided but they do not represent the current complaint condition or a device malfunction i.E broken.According to the information received, "it was reported that the left femoral trial broke in half when being inserted." the product was not returned to medtech orthopaedics; however, photos were provided for review.See attachment ¿(b)(4)." the investigation was not able to confirm the reported event as the complaint condition was not represented clearly in the provided photo.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the photographs provided are not representative of the reported complaint condition.Based on the investigation findings, no problem was detected 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 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.

• Brand Name: ATTUNE PS FEM TRIAL SZ 5 LT
• Common Device Name: FEMORAL 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 46581-0988 ; 3035526892
• MDR Report Key: 20521323
• Report Number: 1818910-2024-22104
• Device Sequence Number: 8855490
• Product Code: HWT
• UDI-Device Identifier: 10603295134077
• UDI-Public: (01)10603295134077(10)MVMBWZ040
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/24/2024

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: 254500735
• Device Lot Number: MVMBWZ040
• 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: 10/14/2024
• Supplement Date Received by Manufacturer: 11/07/2024; 11/18/2024; 11/27/2024; 12/17/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 11/08/2024; 11/20/2024; 11/28/2024; 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2014
• 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
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Female