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

Model Number	214640
Medical Device Problem Code	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: according with the information provided, it was reported that the clever hook does not close properly.The complaint device was received and evaluated.Visual inspection revealed that the device is in normal usage condition.When performing the functional test, it was not possible to open or close the jaws due to the internal shaft was found to be loose.According with the visual inspection and functional test results, this complaint can be confirmed.The possible root cause for the reported condition can be attributed to the age and the constant use of the device that wears away it's internal parts.Since this device is reusable, the metal begins to lose it's shape due to the continuous use causing wear of internal components.However this cannot be conclusively determined.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during a shoulder arthroscopy rotator cuff repair procedure on an unknown date, it was observed that the clever hook device did not close properly.During in-house engineering evaluation, it was determined that it was not possible to open or close the jaws on the device as the internal shaft was found to be loose.Another like device was used to complete the procedure with a delay of 10 to 15 minutes.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: 11147095
• Report Number: 1221934-2021-00082
• Device Sequence Number: 3920233
• Product Code: NBH
• UDI-Device Identifier: 10886705004218
• UDI-Public: 10886705004218
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 01/08/2021

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: 214640
• Device Catalogue Number: 214640
• Device Lot Number: 11K02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1