MAUDE Adverse Event Report: DEPUY MITEK LLC US CLEARCANNULA-THREADED 8.5MMX75MM 5PK -ST; 214120

Model Number	214120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).The lot number was unknown.Investigation summary: according to the information provided, it was reported that rubber bung of cannula broken intraoperatively.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation, however the customer provided a photo, upon visual inspection of the photo, it could be observed that the cannula is showing the silicone bung damaged.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the inspection of the photo, this complaint can be confirmed.The possible root cause for reported failure can be attributed to procedural variables, such handling of the device or product interaction during procedure; excessive force being applied to pass instruments through the cannula which would cause damage to the silicone bung, 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.
Event or Problem Description
It was reported by the sales rep in (b)(6) that during an unknown surgery on an unknown date, it was observed that the rubber bung on the clearcannula-threaded 8.5mmx75mm device was broken.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: CLEARCANNULA-THREADED 8.5MMX75MM 5PK -ST
• Common Device Name: 214120
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12467337
• Report Number: 1221934-2021-02693
• Device Sequence Number: 3780170
• Product Code: GEA
• UDI-Device Identifier: 10886705003617
• UDI-Public: 10886705003617
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/08/2021

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: 214120
• Device Catalogue Number: 214120
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1