MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHRO SIXTER-LEFT *EA; SKIN/TISSUE HOOK

Model Number	214643
Medical Device Problem Codes	Break (1069); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Investigation summary: the complaint device was received for evaluation.Upon visual inspection, it could be observed that the device is in normal usage conditions, no bendings or structural damages could be found.When testing, it was confirmed that the jaw cannot be opened when slightly pressure was applied.The device was sent to the manufacturer for further review.Manufacturer evaluation result for arthro sixter-left *ea.Visual inspection: shear pin found to be partially broken.The safety shear pin has been broken because of excess force used on the device during use.The safety pin is designed to avoid breaking of the device within the operation area and avoid falling of metal pieces in the body of the patient.The root cause can be attributed to an excessive force used by end user.During 2019-2022 tag produced 710 units of sixter left mitek instruments.No complaints were received during that period a manufacturing record evaluation was performed for the finished device 16d03 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.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 affiliate in (b)(6) that during an unknown surgery on an unknown date, it was observed that the arthro sixter-left device was not functioning reliably as it would penetrate the tissue but did not open.During in-house engineering evaluation, it was determined that the safety shear pin was partially broken.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Common Device Name: SKIN/TISSUE HOOK
• 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: 13685334
• Report Number: 1221934-2022-00757
• Device Sequence Number: 5111282
• Product Code: NBH
• UDI-Device Identifier: 10886705004249
• UDI-Public: 10886705004249
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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 Expiration Date: 12/31/2018
• Device Model Number: 214643
• Device Catalogue Number: 214643
• Device Lot Number: 16D03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 03/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown