MAUDE Adverse Event Report: DEPUY MITEK LLC US REUSABLE OBTURATOR 7.0 X 75MM; SURGICAL DRILL GUIDE OBTURATOR

Model Number	214113
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This is report 1 of 3 for (b)(4).It was reported by a healthcare professional that preoperatively to an unknown procedure on (b)(6) 2023, it was observed that the reusable obturator 7.0 x 75mm device was contaminated upon inspection.It was unknown if and how the procedure was completed.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
Additional 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: udi: (b)(4).D4: the expiration date is currently unavailable.H4: the device manufacture 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.
Additional 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.
Additional 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: investigation summary - the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.The complaint device was received and evaluated.Upon visual inspection, the device has no structural anomalies or damages.Under magnification into the center canal, no contamination or other type of matter was found inside.A manufacturing record evaluation was performed for the finished device 65835, and no non-conformances were identified.According with the physical inspection result, this complaint cannot be confirmed.A manufacturing investigation was performed; as a result, shafts are passivated, and have a final clean and package work instruction (wi 1426); the steps have instructions of clean inside and entire device, inspection of the cleanliness and it is placed in a anti-roll cap to seal in the bag.Cleaning, packaging, and visual controls per our work instructions would catch this condition.The work instruction wi 1426 guarantees the cleaning of each device before packaging, after clean and inspect each part, the device is installed one tube.Unable to confirm storage conditions outside the manufacturing site.Visual controls in the packaging work instructions.The lot number on the device indicates this was manufactured in 2022.As per ifu- 108410, follow the instructions and warnings issued by the suppliers of any cleaning and disinfection agents and equipment used.Highly alkaline conditions can damage products with aluminum parts.Avoid exposing instruments to hypochlorite solutions, as these will promote corrosion.The responsibility of the end user to ensure that the cleaning and sterilization is performed using appropriate equipment, materials, and personnel to achieve the desired result.Prior to sterilization, instruments should be cleaned by either automated or manual means described below.Follow the instruction process of cleaning, rising and frying.Place depuy mitek instrument in the appropriate location within the depuy mitek sterilization tray.If a specific location is not identified for an instrument, it may be placed in the general-purpose area (pin-mat) ensuring that the sterilant has adequate access to all surfaces including difficult to reach areas, lumens, etc 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: REUSABLE OBTURATOR 7.0 X 75MM
• Common Device Name: SURGICAL DRILL GUIDE OBTURATOR
• 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: 17128487
• Report Number: 1221934-2023-02406
• Device Sequence Number: 6457968
• Product Code: LXH
• UDI-Device Identifier: 10886705003549
• UDI-Public: 10886705003549
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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,User Facility
• 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 Model Number: 214113
• Device Catalogue Number: 214113
• Device Lot Number: 65835
• 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: 05/31/2023
• Supplement Date Received by Manufacturer: 07/05/2023; 07/13/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/06/2023; 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown