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

Catalog Number	214643
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Udi: (b)(4).Investigation summary: the complaint device was received and inspected for visual and functional anomalies.Visual inspection confirms the tip of the device is slightly bent.Therefore, this complaint can be confirmed.The information provided is not sufficient to determine a definitive root cause, however, one possible root cause can be attributed to excessive mechanical force being applied on the device during use.Hence, causing the reported failure.However, no anomalies were identified during functional testing.The device functions as intended.Furthermore, the potential cause for this issue is not related 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 customer via phone that during an arthroscopy procedure, it was found that the tip of their arthro sixer left was bent.The procedure was completed with another like device with no patient harm or surgical delay to the case.During in-house engineering evaluation, it was determined that the tip of the device was slightly bent.There was no delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Common Device Name: SKIN/TISSUE HOOK
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9546027
• Report Number: 1221934-2020-00021
• Device Sequence Number: 11324046
• Product Code: NBH
• UDI-Device Identifier: 10886705004249
• UDI-Public: 10886705004249
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2020

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 Catalogue Number: 214643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1