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

Catalog Number	214640
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4), incomplete.The lot number is not currently available.Investigation summary: the complaint device is not being returned, multiples attempts for product return were made with no response, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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.This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
This is report 1 of 2 for the same event.It was reported by the customer via phone that during a shoulder repair the customer's clever hook-left and clever hook-right were bent halfway down the shaft.The condition of the devices was noticed before being used on the patient.The procedure was completed with other like-devices, and there was no harm to the patient or delays to the case.The customer was not present for the case, therefore could not provide any additional information or lot numbers for the devices, but stated the devices are less than a year old.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: 9103785
• Report Number: 1221934-2019-58430
• Device Sequence Number: 13915548
• Product Code: NBH
• UDI-Device Identifier: 10886705004218
• UDI-Public: 10886705004218
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2018

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: 214640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1