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

Model Number	214643
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Investigation summary: according to the information received, it was reported that the "sixter" instrument in the loan kit was blunt during use passing through the labrum and that it needed to be replaced.He was eventually able to use it, but with greater force than usual.The complaint device was received and evaluated.Visual observations reveals that the device was dull and presented marks of wear at the handle.In addition, the shaft was bent.When observed the jaws under magnification, didn't present edge at the tip.The functional test was performed in a sample rubber strip, as result, the jaw pass satisfactorily trough the rubber but using a greater force than normal.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.The complaint can be confirmed.Since this is a reusable device, this failure has possibly occurred after using it in this manner for many procedures.The possible root cause for the reported failure can be attributed to the blunt jaws, also can associated to the repeated use of the device causing normal wear and tear.However, this cannot be conclusive determined.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.
Event or Problem Description
It was reported by the affiliate in australia that during a shoulder repair procedure on (b)(6) 2020, it was observed that the sixter device was blunt while passing through the labrum.During in-house engineering evaluation, it was determined that the shaft was bent.The same device was used but with greater force than usual to complete the procedure without delay.There were no adverse patient consequences 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
• MDR Report Key: 11195569
• Report Number: 1221934-2021-00142
• Device Sequence Number: 4607031
• Product Code: NBH
• UDI-Device Identifier: 10886705004249
• UDI-Public: 10886705004249
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 01/15/2021

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: 214643
• Device Catalogue Number: 214643
• Device Lot Number: 12K01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1