MAUDE Adverse Event Report: DEPUY SPINE INC PEDAL - LENS CLEANING; LAVAGE, JET

Catalog Number	286003310
Medical Device Problem Codes	Break (1069); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that on an unknown date in 2025, the foot pedal broke on the teligen unit.The device was put away after a surgery and when it was brought back out, it had stopped working.
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 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.H11 additional narrative: h6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.H3, h6: product was not returned.Based on the information available, it has been determined that no corrective and 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.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.H11 additional narrative: added: h6 medical device problem code 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.Note: following investigation was performed by the supplier.Please refer to the attachment " (b)(4) investigation teligen foot pedal mar 2025 - signed" for investigation results.Although distributed by medtech orthopaedics (spd) the product is designed, manufactured, and labeled by the manufacturing supplier.The requirement of fda reporting, complaint investigation, root cause, and corrective action is the responsibility of the designing supplier of this item, per the supplier agreement.The product/information will be transferred to the supplier with the complaint problem statement for investigation.The results of the supplier investigation are to be populated into the medtech orthopaedics customer quality complaint management system.Per the supplier agreement, the supplier is responsible for any corrective actions identified during the complaint investigation process.H11 additional narrative: added: d9.H3, h6: the product was returned to medtech orthopaedics for evaluation.The medtech orthopaedics team forwarded the device to the supplier which conducted a visual inspection of the returned device.This serial numbered product was from a known population of foot pedals that have shown a higher than expected out-of-box failure rate.This pedal shows signs of significant use, where powder coating is worn and chipped on pedal base.No patient harm reported with this complaint.Supplier (b)(4) systems was notified.Rma pending.Corrections are already implemented at oem suns.Will return device to (b)(4)/suns for verification of failure mode (wire short, control chip cold solder (open) or other) and replacement.As part of medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the 286003310 and pedal - lens cleaning.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PEDAL - LENS CLEANING
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): NORTECH - MILACA, MN; 925 6th avenue ne; milaca MN
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 21304730
• Report Number: 1526439-2025-00173
• Device Sequence Number: 8848103
• Product Code: FQH
• UDI-Device Identifier: 10705034555164
• UDI-Public: (01)10705034555164
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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

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: 286003310
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: 02/10/2025; 03/06/2025; 03/25/2025; 04/03/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 02/13/2025; 03/06/2025; 03/26/2025; 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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