MAUDE Adverse Event Report: DEPUY MITEK LLC US REUSABLE OBTURATOR 5.5 X 75MM; SURGICAL DRILL GUIDE OBTURATOR

Model Number	214105
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
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).The lot number was unknown.D4, g1, h4: the lot number was unknown; therefore, the expiration date, manufacturing site name and device manufacture date were unknown.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 or Problem Description
This is report 2 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 5.5 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.The actual device has been returned and is currently pending evaluation.Once the investigation has been completed, a supplemental medwatch report will be submitted accordingly.
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 mitek or its employees that the report constitutes an admission that the device, 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.Investigation summary: 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 material was found inside.A manufacturing record evaluation was performed for the finished device 64251, and no non-conformances were identified.According with the physical inspection result, this complaint cannot be confirmed.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, this product may have not stored as to the ifu requirements, the condition of similar products with different lot numbers and manufactured at different times and years have the same problem of rust which can be related to an improper storage.Since no contamination could be found inside the device this complaint cannot be confirmed.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 5.5 X 75MM
• Common Device Name: SURGICAL DRILL GUIDE OBTURATOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17128485
• Report Number: 1221934-2023-02405
• Device Sequence Number: 12376417
• Product Code: LXH
• UDI-Device Identifier: 10886705003464
• UDI-Public: 10886705003464
• 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: 214105
• Device Catalogue Number: 214105
• Device Lot Number: 64251
• 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: 10/24/2023; 11/15/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 10/25/2023; 11/16/2023
• 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