MAUDE Adverse Event Report: DEPUY MITEK LLC US CLEARCANNULA-THREADED 7.0MMX75MM 5PK -ST; ARTHROSCOPIC DRAINAGE CANNULA

Model Number 214116

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).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

It was reported by the customer in (b)(6) that during a rotator cuff repair surgery on (b)(6) 2022, it was observed that there was a small black spot inside the package of the clear cannula-threaded 7.0mmx75mm 5pk -st device.The package was not opened and another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay 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 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.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.Investigation summary : the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received and photo provided by the customer.Visual inspection revealed that the package of the device was unopened, and the tray was not damage.It was observed a foreign matter inside the package, and it is unknown what it is; therefore, the device was sent to manufacturer.The photo showed the same condition found during the physical analysis.The certificate of analysis and certificate of compliance for this manufactured lot was reviewed and there were no non-conformances or deviations for this lot on the coc.Based on the visual inspection; this complaint can be confirmed.A ft-ir (fourier transform infrared spectroscopy) test was performed by the manufacturer, the purpose of this analysis is to identify chemical composition.The results of the ftir showed that the spectrum of the foreign matter and some part material are the same; see attachment "(b)(4) analysis¿.As agreed, a nonconformance record was created to document the root cause and identify a corrective and/or preventive action plan.A manufacturing investigation was performed; as a result, the operator will put the product in the anti-static device to eliminate the foreign matter and put it into the auto-packing machine.There are 100% visual inspection the product after the packaging is completed.The inspection for the above criteria shall be performed without magnification under normal room lighting.The product is to be viewed at a distance of 12 to 15 inches for approximately 3 seconds.Qc sampling based on qc plan definition and recording the sampling result, please refer to the attached.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthese mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: CLEARCANNULA-THREADED 7.0MMX75MM 5PK -ST
• Type of Device: ARTHROSCOPIC DRAINAGE CANNULA
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13426443
• MDR Text Key: 288619874
• Report Number: 1221934-2022-00375
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10886705003570
• UDI-Public: 10886705003570
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• 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

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 214116
• Device Catalogue Number: 214116
• Device Lot Number: 2101243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1