MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MTO ATTUNE BALANCER SIZER; SIZING/MEASURING INSTRUMENTS

Catalog Number	299965994
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ps foot of the instrument would no fully engage and became stuck upon trying to remove from the instrument body.Product was marked "nfcu" as it was intended for training purposes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch 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: according to the information received, "on 16 aug 2023, knees r&d co op wwid (b)(6) was reviewing the function of the mto attune balancer sizer (pn 299965994, lot bp0116930) at his desk for educational purposes.The instrument was provided to him by marketing manager wwid (b)(6).During his reviewing he identified the ps foot of the instrument would no fully engage and became stuck upon trying to remove from the instrument body.Product was marked "nfcu" as it was intended for training purposes." the device associated with this report was returned to depuy synthes customer quality.Functional testing of the returned mto attune balancer sizer (p/n 299965994, lot: bp0116930), confirmed the ps foot component of the instrument would not fully engage with the instrument body.Upon further visual examination of the ps foot, there appears to be excess material inside the slot inhibiting the mating component to be able to fully seat.In the event additional unrecommend force was applied, the two components could become stuck together and unable/difficult to disassemble due to the defect on the ps foot component.Based on the visual analysis and functional tests confirming the reported event, dimensional inspection was not performed.The overall complaint was confirmed as the observed condition of the mto attune balancer sizer would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to manufacturing.The product issue has been addressed through depuy synthes quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device lot number bp0116930, and previous no non-conformances were identified.(b)(6) was created to document the current reported issue.

• Brand Name: MTO ATTUNE BALANCER SIZER
• Common Device Name: SIZING/MEASURING INSTRUMENTS
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17595945
• Report Number: 1818910-2023-17192
• Device Sequence Number: 12395820
• Product Code: HWT
• UDI-Device Identifier: 10603295453277
• UDI-Public: 10603295453277
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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
• Report Date (Section B): 08/22/2023

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: 299965994
• Device Lot Number: BP0116930
• 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: 08/16/2023
• Supplement Date Received by Manufacturer: 08/24/2023; 08/30/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 08/24/2023; 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2019
• 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