MAUDE Adverse Event Report: SYNTHES GMBH MAXFRAME(TM)FOOT PLATE SUPPORT KIT; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, MULTI COMPO

Catalog Number	03.312.010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, the rubber on the foot rocker is removing and the patient slept postoperatively.This report is for one (1) maxframe(tm)foot plate support kit.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
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 the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E1: initial reporter email address: (b)(6).H3, h4, h6: device history record (dhr) review conducted: part number: 03.312.010-us lot number: 9813p60 part manufacture date: 02/26/2024 manufacturing location: brandywine part expiration date: n/a nonconformance noted: n/a a review of the device history record of this lot revealed no complaint-related anomalies.The device history record shows that the maxframe foot plate was processed through all operations on the released routing for part number 03.312.010-us and met all inspection specification requirements at the time of release with no issues documented during manufacture that would contribute to this complaint condition.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
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 the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: the product was returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned device confirms the broken condition, the rubber section of the maxframe(tm)foot plate support kit is peeling off.In addition, the subcomponents of the device standoff height sleeve short, t bolt short, standoff height sleeve, long, t bolt, long were not returned for evaluation.There is no indication that a design or manufacturing issue has caused the complaint condition hence the root cause cannot be established a dimensional inspection was not performed due to post manufacturing damage.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the maxframe(tm)foot plate support kit 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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review part number: 03.312.010.1 lot number: 5065p22 part manufacture date: 12/11/2023 manufacturing location: brandywine part expiration date: n/a nonconformance noted: n/a a review of the device history record of this lot revealed no complaint-related anomalies.The device history record shows that the foot support - right was processed through all operations on the released routing for part number 03.312.010.1 and met all specification requirements at the time of release with no issues documented during manufacture that would contribute to this complaint condition.Product lot met all inspection specification requirements at the time of release with no issues documented during manufacture that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
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 the information is unknown, not available or does not apply, the section/field of the form is left blank.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MAXFRAME(TM)FOOT PLATE SUPPORT KIT
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, MULTI COMPO
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 20091870
• Report Number: 8030965-2024-10455
• Device Sequence Number: 20774561
• Product Code: KTT
• UDI-Device Identifier: 10886982260970
• UDI-Public: (01)10886982260970(10)5065P22
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161417
• 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

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: 03.312.010
• Device Lot Number: 5065P22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 12/20/2024; 03/07/2025
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 12/30/2024; 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown