MAUDE Adverse Event Report: DEPUY MITEK LLC US RESTORE FULLY FLUTED REAMER 6.5MM (PLUS OR MINUS 5 PERCENT); CANNULATED SURGICAL DRILL

Model Number 219553

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, 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 narrative: udi: (b)(4).The expiration date is currently unavailable.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

This is report 8 of 15 for (b)(4).It was reported by the field service engineer that during inspection, the customer observed that the restore fully fluted reamer 6.5mm (plus or minus 5 percent) device had contamination inside its cannulated section.According to the report, the event occurred before processing when the customer decided to inspect the device with their borescope.It was reported that the device was purchased on (b)(6) 2022; and has never been used.It was further reported that the device was shelved and stored in controlled environment in the sterile processing department.There was no procedure nor patient involvement reported.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, 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.Investigation summary :the complaint device has not been returned, therefore unavailable for a physical evaluation.However, photos were provided.Upon visual inspection of the photos, the devices were observed in a sterilization tray and not in its original packaging.Under magnification, one photo showed evidence of contamination in the canal.It is unknown which product was observed in the photo.This complaint can be confirmed.A manufacturing record evaluation was performed for the finished device 2104512, and no non-conformances were identified.The photo does not provide enough evidence to determine root cause.Physical evaluation should provide more information to discern a possible root cause.As per ifu, the precautions for this type of device consist of to inspect the condition of the device prior to use.For the instrument life, it is necessary to follow the instructions and warnings of any cleaning and disinfection agents and equipment used; also, the recommendation of the proper condition during the sterilization and maintenance to avoid any damage.Follow the instructions and warnings issued by the suppliers of any cleaning and disinfection agents and equipment used.Avoid exposing instruments to hypochlorite solutions, as these will promote corrosion.Avoid prolonged exposure to saline to minimize the chance of corrosion.Prior to sterilization, instruments should be cleaned by either automated or manual means described below.Dry the instrument immediately after final rinse.Use filtered compressed air to dry internal areas.After drying proceed to inspection instructions.Inspect all instruments before sterilization or storage to ensure the complete removal of soil from surfaces, tubes and holes, moveable parts.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, 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.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, 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.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.H10 additional narrative: investigation summary : the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Upon visual inspection, marks of sterilization and use near the distal tip can be observed.Under magnification into the center canal, no rests of a brownish matter were observed.A manufacturing record evaluation was performed for the finished device 2103001, and no non-conformances were identified.According with the physical inspection result, this complaint cannot be confirmed.The manufacturer performed an investigation with the following results: paragon performs 100% visual inspections, and borescope inspections for cannulated product where required.All products go through a validated final wash (and passivation where applicable) process according to the depuy contamination control policy and per internal procedure.The passivation tanks are measured and adjusted to maintain proper concentricity daily.Based on timing of deliveries ((b)(6) 2019, (b)(6) 2022) along with acknowledgement that acceptance of product at depuy prior to shipment to hospital, and prior to use in medical procedures, the product condition paragon is responsible for was met or accepted at depuy, therefore product acceptance from paragon perspective was met.Paragon has performed a review of its manufacturing history files on these lots and determine the product was manufactured according to customer specifications, with no anomalies observed.Product was accepted by depuy, which constitutes the scope and limit of paragon¿s ability to investigate or contribute to this issue.Paragon does not have ability to determine risks or issue root causes after distribution or use in procedures.The external factors that could have caused the reported issue are unknown.As per ifu: stating that the products must be stored in a manner to protect from dust, moisture, insects, vermin and extreme of temperature and humidity.These products should be subjected to room temperature.To the information provided and as to our estimate, these products were not stored as to the ifu requirements, the condition of these tunnel dilators products with different lot numbers and manufactured at different times and years have the same problem of rust which can be related an improper storage.Based on the visual inspection results, this complain can be confirmed.The device was manufactured on 3/19/2021 and is more than 2 years old.Hence indicates that is more than two years old.Therefore, a possible root cause can be attributed to the storage conditions after the device was manufactured.However, this cannot be conclusively determined.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: RESTORE FULLY FLUTED REAMER 6.5MM (PLUS OR MINUS 5 PERCENT)
• Type of Device: CANNULATED SURGICAL DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 16386084
• MDR Text Key: 309668768
• Report Number: 1221934-2023-00788
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886705006748
• UDI-Public: 10886705006748
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• 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

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 219553
• Device Catalogue Number: 219553
• Device Lot Number: 2103001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1